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PerkinElmer jobs in Trenton, NJ - 47 jobs

  • Marketing Manager

    Perkinelmer 4.8company rating

    Perkinelmer job in Princeton, NJ

    When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services. Job TitleMarketing Manager Location(s) Cambridge, MA, Cambridge (UK), Columbia, SC, Indianapolis, IN, Miami, FL, Orlando, FL, Princeton, NJ, Rahway, NJ, Raleigh, NC, Richmond, VA, Summit, NJ, Tampa, FL, US Remote - NC, West Point, PA, Westwood, MA Job Description Brand Development & Stewardship Support the creation and roll-out of the OneSource Life Sciences master brand and sub-brand architecture. Partner with leadership on the brand narrative, value messaging, positioning, and visual identity. Ensure brand consistency across all business units, marketing channels, and customer-facing materials. Manage the development of brand guidelines and enable cross-functional teams to adopt them. Website Creation & Launch Oversee the end-to-end build of the new OneSource Life Sciences website, including content, structure, user experience, and vendor management. Coordinate internal SMEs (labs, PF, technology solutions) to supply accurate content and proofing. Ensure the website reflects the new brand, showcases our capabilities clearly, and supports lead generation. Manage launch timeline, testing, QA, and post-launch optimization. Marketing Strategy, Campaigns & Execution Support the annual marketing plan for brand awareness, customer retention, and account growth. Develop and maintain sales collateral, capability decks, case studies, and customer-facing content. Partner with sales, account management, and operations leaders to understand market needs and create relevant materials. Manage general marketing requests from across the organization with clarity and prioritization. Assist in development of digital campaigns (email, web, social) to drive awareness and demand. Track performance metrics to support continuous improvement. Account-Based Marketing (ABM) Support Work with the VP, Marketing & Strategy to operationalize the ABM strategy for top-tier accounts. Build targeted content, messaging, and materials tailored to strategic clients and verticals. Coordinate with sales and account teams to understand account goals, decision-maker needs, and buying journeys. Manage ABM deliverables such as personalized microsites, targeted campaigns, executive briefings, and customer value stories. Partner with analytics teams to measure engagement, track movement across the account lifecycle, and report on campaign impact. Ensure ABM programs reinforce the new brand and support long-term customer relationships. Cross-Functional Collaboration Work closely with Project Farma, Lab Solutions, and Technology Solutions teams to unify messaging. Collaborate with HR, legal, and corporate marketing teams to ensure alignment and compliance. Support event marketing for conferences, summits, and customer engagements. PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
    $106k-145k yearly est. Auto-Apply 21d ago
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  • Consultant / Senior Consultant

    Perkinelmer, Inc. 4.8company rating

    Perkinelmer, Inc. job in Trenton, NJ

    Responsibilities This is a fully onsite role with Project Farma, a PerkinElmer company Consultants and Senior Consultants are fully billable roles that will work collaboratively withclients, vendors, contractors, and other Team Members tolead andsupport projects related tobiomanufacturing across the entireprojectlifecycle.Specifically, theyare responsible forleading and mentoringsmall project teamsandidentifyingbusiness development opportunitiesthrough Project Farma'sPatient FocusedandPeopleFirstplatform. Consultants and Senior Consultants are tactical executors focused on project-level delivery, supporting thesite Manager's strategy, and contributing to business growth, talent development, and resource planningwith an emphasis ontechnicalexpertiseand operational execution. EssentialFunctions: Site Strategy * Executes the site strategy as defined by the Manager to support the firm's leadership position in CQV services. * Identifiesclient needs during project execution and communicates these to the Manager for strategic consideration. * Builds andmaintainsrelationships with key project Points of Contact (POCs), such as project managers or technical leads, to ensure smooth project delivery and client satisfaction. Business Growth & Development * Participate in project extensions and proposal generation, providing technical and operational input. * Attend market-based industry events to build a local network. * Provide deliverable and resource recommendations for site proposals to ensure feasibility. * Support Project Farma's business development initiatives through proactively identifying and escalating client needs along with a proposed support plan to their Managerappropriately. * Understand and be able to speak to services both internally and externally. * Maintain and present site dashboards to communicate project health, growth opportunities, and account maintenance needs. * Communicateopportunities to expand presence and services for client support. * Foster positive relationships with key stakeholders. * Generateproposedsupport plan and escalate that plan as needed. * Learn and develop skills and understanding of the business developmentprocessincluding proposal generation. Talent Development * Encourage team members to share best practices within the team or site, contributing to a collaborative culture. * Foster accountability and excellence within the project team andcommunicatesretention risks (e.g., team morale issues) to the Manager. * Coach Team Members onidentifiedknowledge gaps and direct Team Members to materials to develop project driven technical and problem-solving skills * Mentor and train internal team members on assigned duties, industry best practices, overall understanding of the business, andproject driventechnical skills. * Develop team members with foresight to support project succession plans asidentifiedby leadership. * Develop andmaintainyour own succession plan to ensure project continuity. Technical Delivery * Escalate technical delivery issues to the Manager and provide resolution or mitigation solutions. * Ensure delivery of high-quality GMP Engineering services that meet client specifications, regulatory requirements, and industry standards. * Support project execution, from planning tocloseout, ensuring timelines and budgets are met. * Lead, oversee, and execute client project initiatives, plans, or workstreams including ensuring team deliverables are completed ina timelyand high-quality fashion. * Provide hands-on support for both clients and Project Farma Team Members in navigating the engineering life cycle ofcutting-edgeequipment and manufacturing processes including proactively identifying and escalating roadblocks andutilizingcritical thinking skills and knowledge of problem-solving skills toidentifycreative solutions. * Create, update, and present work projections and progress reports. * Develop technical documentation such as SOPs, requirements specifications, testing protocols, summary reports,etc. * Build internal and external understanding, buy-in, and commitment to decisions through mutual understanding, collaboration, and effectivepresentationsskills. * Maintain PO managementtools;managing burnrates;needs for new proposals and proactively communicate PO performance. * Coordinate Team Memberutilizationwith Site and Account Leads and escalate discrepancies between actual and forecastedutilization. * Maintain internal site tools such as site dashboards, deliverable trackers, etc. * Continually develop technical aptitude of Project Farma's core services within the life science space including but not limited to:Capital Project Management, including Project Controls and Scheduling,Facility Builds,Tech Transfers,Validation Life Cycle, including CQV Process, Computer System Validation,Quality, Regulatory, and Compliance,GxPAutomated Systems,Quality Control, including Clinical and Commercial. * May be requested toassistwith Project Controls and Scheduling toinclude;budget estimates, detailed project schedules, feasibility estimates, risksand forecast analysis as well as project cost reports and trends. Operational Performance,Billability& Resource Management * Maintains 100% individual billability, focusing on personal contribution to project hours. * Provides input into resourcing decisions for the project team to ensure high-quality delivery. * Consultswith the Manager to forecast future resource needs for the project and contribute to the resource plan. Leadership and Philanthropy * Contribute to and embody our Patient FocusedandPeople Firstmission,ensuring philanthropic and professional development opportunities are available for the site. * Coach and mentor Team Members on solution driven mindset. * Activelyseeksopportunities to enhance Project Farma'sculture, support internal initiatives, and continue to develop servant leadership skills. * Buildandmaintaindeep rooted and meaningfulinternal and external relationships. Qualifications: Education and Experience Required: * 5-7years'experience in consulting and/or engineering services. * Bachelor's Degree in Life Science, Engineering, or related discipline (OR a combination of equivalent work experience in CQV engineering, cGMP facility start-up, projectmanagementand/or comparable military experience). Other Required: * Full-timeon-site client presence * Willingness to travel up to 100% or asrequired. Key Competencies: * Customer Focused:Able toidentify, prioritize,and escalate client needs and recognize constraints.Seeksto find out more about our clients, build meaningful relationships with clients, and provide excellent servicetowardsthe customer. * Problem Solving:Able toidentifykey components of problems, generate and evaluate proposed solutions or mitigation plans, and choose the mostappropriate option. * Teamwork and Collaboration: Activeparticipantinteamenvironment andworkstogether towards a common vision and/or goal.Encourages and embraces cooperation and collaborationamongst teams. * Initiative: Able to completedeliverablesor work unassisted.Takesresponsibility for their own time and productivity.Actively seeks out new things to learn. * Flexibility and Adaptability:Able to respond positively toand communicatechangeto teams.Adapt to new situations quickly.Able to take on a diverse range of tasks whileremainingequally effective.Handles competing demands, overcomes setbacks, welcomes, and learns from constructive feedback. * Integrity:Demonstratescommitment to corporate and personal values.Takesaccountability for their actions, decisions, and work.Exhibitsa high standard of ethics.Buildsandmaintainstrust and good working relationships.Demonstrates honesty and truthfulness at all times. * Accountability:Demonstratesa high levelof self-awareness.Holds self and others accountable for measurable,high-quality,timely, and effective results.Determinesobjectives, sets priorities, and delegatesworkthrough to the end. * Leadingand DevelopingOthers:Ability to communicate effectively, mentor and develop others,andbuild andmaintainrelationships.Proactivelyidentifyperformance trends and developmental and/or stretch opportunities for Team Members. Applicants must be authorized to work in the United States on a full-time basis. We will not sponsor applicants for current or future work visas for this position. This position may require significant travel to support project and business needs. We cannot employ anyone with an invalid driver's license.
    $106k-133k yearly est. 12d ago
  • Lead Manufacturing Operator

    Integra Lifesciences 4.8company rating

    Plainsboro, NJ job

    Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. This Lead Manufacturing Operator will provide daily direction to the manufacturing floor based on production schedule, available resources and department priorities. Engage and support manufacturing process to assure timely completion and quality throughput. Lead and support administrative activities such as training, investigations, procedure development and inventory management within the manufacturing area. Drive a positive culture within the manufacturing environment through teamwork, engagement and respect. SUPERVISION EXERCISED This role will lead Clean Room Operators ESSENTIAL DUTIES AND RESPONSIBILITIES People Allocate resources to meet daily schedule needs and support recover plan development and execution Partner with area management to identify overtime needs in advance Communicate with support groups to on daily processing needs Provide feedback to department management on operator and process performance Interface with support departments to establish clear/consistent manufacturing objectives and needs Process Perform all requirements of a Manufacturing Operator Provide daily oversight of manufacturing operations in the suite Actively engage in all areas of the manufacturing process Identify and resolve training gaps (process, performance, paperwork) through the execution of a training plan Own operator training for all new Chemical Operators Lead troubleshooting initiatives to minimize equipment/process downtime Perform manufacturing suite walk through activities to identify equipment deficiencies and observe operator execution Support investigations as a subject matter expert Maintain process and component inventories Support time management around start/stop, breaks and timely completion of tasks Paperwork Obtain batch records in advance for associated manufacturing operations to prevent delays Document manufacturing activities in real time and perform daily in-process checks of paperwork Supply and receive paperwork from support groups when necessary to keep manufacturing operations on track and progressive Provide comments in batch records not limited to non-conformance references or other clarifications Perform daily, in-process reviews of batch records to support good documentation practices Develop, redline, and/or review associated manufacturing documentation To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. DESIRED MINIMUM QUALIFICATIONS The requirements listed below are representative of the knowledge, skill, and/or ability desired for this position. High School diploma or equivalent. Degree in related science a plus. 3-5 years of chemical processing experience or batch mixing in manufacturing environment in the Medical Device or Pharmaceutical industry preferred. Basic computer skills for email and data entry. Must read, write and speak in English, and communicate clearly and concisely. Fundamental understanding of mathematics and chemistry. Able to participate in a team-oriented environment, willingness to assist and train others Able to work independently with minimal supervision Understand product flow and understand chemical process and its impact Able to work overtime TOOLS AND EQUIPMENT USED Lyophilizers, homogenizers, Tornado Mill, vacuum pump, pH meters, thermometers, balances (scales), water bath circulators, humidity cabinet, centrifuge, blenders, air gun, Filamatic filling machines, drop indicator, scalpels, pouch sealers and Honeywell temperature recorders. PHYSICAL REQUIREMENTS Ability to gown to ISO Class 5 type Clean Room standards and/or additional Clean room clothing. Ability to gown to ISO Class 7 type Clean Room standards and/or additional Clean room clothing. Vision: Requires eyesight correctable to 20/25 to detect any defect in product/materials. Visual acuity adequate to perform job duties, including meeting all of quality reclassification. Requires normal color perception. The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position. Salary Pay Range: $26.21 - $35.38 USD Hourly Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following ******************************************* Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at ***********************. Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails. Integra - Employer Branding from Integra LifeSciences on Vimeo
    $26.2-35.4 hourly Auto-Apply 60d+ ago
  • Clinical Education Delivery Consultant - IR/CV (Travel: East Zone - PA)

    Philips Healthcare 4.7company rating

    Philadelphia, PA job

    Job TitleClinical Education Delivery Consultant - IR/CV (Travel: East Zone - PA) Job Description Bring your passion for patient care and technology to this role where you'll be responsible for leading the delivery of Image Guided Therapy (IGT) clinical education to Philips customers. You will provide, basic through intermediate, application training in hospitals and clinics throughout the specific geography. Your role: Delivering engaging onsite clinical services solutions, education, and training. Guiding customers in testing workarounds, clinical integration, and new functionality of solutions. Ensuring site readiness through collaboration with local sales, service and customer project management teams. Leading and owning the learning experience through customer consultation and collaboration with internal stakeholders. Providing an excellent customer experience for onsite training and customer communication. Providing continuous and effective communication on project status, including issues and delays, with internal teams. Building communication and encouraging collaboration within the learning audience. Gaining complete knowledge of relevant solutions per modality; obtaining advanced proficiency in areas of specialization. Addressing and resolving a diverse scope of problems; demonstrating good judgement in identifying methods/techniques for obtaining solutions. Approximately 90% travel across the East Zone (CT, DE, MA, MD, ME, NC, NH, NJ, NY, OH, PA, RI, SC, VA, VT, Washington, D.C., and WV) is required. The average driving time is 1-6 hours daily. Overnight stays and travel by air/train/bus may be required. Travel across the zone is required, and occasional national travel may be required. You're the right fit if: You've acquired 5+ years of experience as a cardiovascular or interventional radiology Registered Radiologic Technologist in a clinical environment. Prior clinical preceptor, clinical training, and/or adult education delivery experience is highly preferred. You must be able to provide verification for current/active certification through the American Registry of Radiologic Technologists (ARRT) and must have an advanced certification in at least one of the following (or required to obtain within 12 months from beginning of employment): Cardiovascular Interventional Radiology (CV), Cardiac Interventional Radiology (CI), Vascular Interventional Radiology (VI), or Registered Cardiovascular Invasive Specialist (RCIS). You have a certificate or associate degree. Bachelor's degree preferred. Certified Technical Trainer Plus (CTT+) is preferred. You're passionate about technology and education related to patient care. You have excellent verbal and written communication and presentation skills. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Clinical position. You must be able to: Work in an office/home office and/or remote setting, as well as in a hospital/healthcare environment; adhere to requirements. Work flexible hours (based on business needs). Safely work with radiation sources and/or radioactive materials. Wear all required personal protective equipment. May be required to comply with vendor credentialing. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is a field role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details The pay range for this position in: DE and PA is $88,000 to $140,000. NJ is $99,000 to $157,000. This role also includes company fleet/car, training, and advancement opportunities. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to one of the following cities: Harrisburg, PA Hershey, PA Philadelphia, PA Pittsburgh, PA Candidates must reside in a city within their territory that holds the majority of the customer base and be located near (within 1 hour drive) a major (non-regional) airport to be considered. This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
    $99k-157k yearly Auto-Apply 8d ago
  • Field Service Engineer, Medical Imaging (Travel: Philadelphia, PA)

    Philips Healthcare 4.7company rating

    Philadelphia, PA job

    Job TitleField Service Engineer, Medical Imaging (Travel: Philadelphia, PA) Job Description Allow your passion for improving lives to shine in this role where you'll be responsible for customer relationship management through the effective use of technical knowledge to install, troubleshoot, service, and maintain equipment at customer sites. Your role: Provide exceptional customer service by adhering to customer entitlements, setting clear expectations, and meeting commitments and arrival times to address and resolve customer needs. Understand the customer's business and competitive environment; generate service revenue. Actively participate as a member of the regional work team; work to improve team processes and identify training gaps. Seek out opportunities to increase capability and capacity (i.e. may be required to become qualified in multiple modalities, learns new tools). Perform all administrative duties within established Philips, State, and Federal regulatory requirements and timeframes including timesheets, service work orders, expense reports, Field Change Orders (FCO), preventative maintenance (PM), installation documents, site and service documentation, and other related paperwork. Adhere to established training, quality, and safety requirements. Utilize tools, support, resources, and escalation processes within required time frames to resolve customer and system problems timely and effectively. Complete PMs, FCOs, installation and all related tasks (diagnose and resolve electronic, network, and mechanical problems). Approximately 70% travel across the specified geography is required. The average driving time is 1-4 hours daily. Occasional overnight stays and travel by air and/or train may be required. You're the right fit if: You've acquired 2+ years of experience in a diagnostic imaging (field or hospital-based) service environment or 4+ years' in electromechanical industries. Preferred experience in Computed Tomography (CT) and/or Diagnostic X-Ray (DXR) imaging equipment. Your skills include the ability to understand and apply electronic, mechanical, and networking theory to install, diagnose, and repair equipment, including knowledge and use of all necessary tools and test equipment. You have an Associate Degree in electronics or equivalent combination of education and experience; BSEE/BSEET/BSME/BSMET preferred. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Field Service position. You must be able to: Work in an office/home office and/or remote setting, as well as in a hospital/healthcare environment; adhere to requirements. Work flexible hours (based on business needs to include overtime, weekends, and on-call rotations). Safely work with radiation sources and/or radioactive materials; wear all required personal protective equipment. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is a field role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details The hourly pay range for this position in PA is $33.00 to $52.00, plus overtime eligible. This role also includes field service and lead generation incentive bonus plans, on-call pay, company fleet/car, training, and advancement opportunities. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive plan, field service incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. For this position, you must reside in or within commuting distance to Philadelphia, PA This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
    $33-52 hourly Auto-Apply 60d+ ago
  • Associate Medical Communications Manager: Medical Writing

    Integra Lifesciences 4.8company rating

    Trenton, NJ job

    Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The **Associate Manager, Medical Writing** is a senior level professional with advanced knowledge and experience in preparing complex clinical and medical writing deliverables. Essential Duties and Responsibilities + Prepares complex clinical deliverables in accordance with internal GSOPs, and regulatory guidelines including clinical sections for regulatory documentation as well as Literature Review Protocols, Literature Review Reports, Clinical Evaluation Plans, Clinical Evaluation Reports, Summary of Safety and Clinical Performance, Post-Market Clinical Follow-Up Plans and Reports within expected deadlines with little oversight. + Ability to perform and document a methodologically sound literature search with little oversight. + Knowledge of European, Australian and Canadian, regulations and guidelines for medical device submissions. + Able to Identify pertinent internal and external sources of clinical data and conducts literature searches of peer review publications. + Contributes to achievement of departmental goals and operating plans + Authors clinical study reports, manuscripts for publication, posters, abstracts or internal white papers. + Partners with subject matter experts, including liaising with external services, to develop technical content that meets regulatory requirements, and to achieve specific and immediate business objectives. + Develops tools, templates, best practices and standard operating procedures to ensure efficient preparation of high-quality medical writing deliverables. Ensures template sections of documents remain current and consistent across documents/Business Units as applicable. + Develops and maintains effective working relationships with co-workers, internal customers, and external vendors. + Mentors and/or trains more junior colleagues **Knowledge, Skills, & Abilities** + Advanced medical and technical writing skills & presentation skills + Demonstrated bibliographic research and editorial skills. + Strong ability to interpret and disseminate relevant product information. + Proficiency in MS Office applications and proficiency in or ability to learn EndNote or Reference Manager. + Understanding of regulatory compliance for medical devices. + Strong organizational skills, attention to detail and proofreading skills. + Maintains general knowledge of industry, regulatory, marketing, linguistic, and publication standards and applies this knowledge to the completion of all projects. + Demonstrated project management skills. + Ability to produce reports and documents independently and evaluate the writing of others. + Demonstrated creativity and ingenuity through the development of novel, multi-disciplinary approaches to projects and strategic issues. + Skill and ability in implementing strategic projects, acting as a catalyst to remove organizational barriers, reduce cycle times and direct process improvements. + Ability to rapidly develop expertise in the company's internal document management system **Qualifications:** + Minimum BA/BS plus 8 years' experience in pharmaceutical/biotechnology industry (5 years for PhD/PharmD level), with at least 5 years as medical writer (3 years for PhD/PharmD). + Expertise with software and templates commonly used in regulatory medical writing (ie, MS-Word, Excel, Powerpoint, Adobe Acrobat). Experience with MS-Project preferred. + Works well and efficiently in fast-paced environment across multiple functional teams. Has solid understanding of the different clinical and regulatory development functional areas and roles. + Positive, flexible, open-minded attitude; thrives in collaborative environment + Medical device experience is preferred (510(k), PMA, BLA, HCTP). + Experience in regulatory writing is preferred. + Skilled in written and oral communications. Meticulous attention to detail. + Able to analyze, interpret, and critically evaluate complex sets of clinical and nonclinical data. + Comfortable leading teams and educating team members as needed during process of document development + Organized, results-oriented, deadline-driven. Experience managing multiple projects + Comfortable taking the initiative, solving problems at hand, and escalating issues as needed Salary Pay Range: $82,000.00 - $113,000.00 USD Salary Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training **.** In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation **.** Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following ******************************************* Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law (********************* | EOE including Disability/Protected Veterans (******************************************************************** Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (************************************************** . If you have difficulty using our online system due to a disability and need an accommodation, please email us at ***********************. Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails. Integra - Employer Branding from Integra LifeSciences on Vimeo (*****************************************
    $82k-113k yearly 28d ago
  • Assistant Treasurer

    Integra Lifesciences Holdings Corp 4.8company rating

    Princeton, NJ job

    Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. SUMMARY DESCRIPTION The Assistant Treasurer is primarily responsible for assisting the Treasurer with managing and executing treasury functions including bank relationship management, foreign exchange operations, cash management, policies and treasury operations. Additional responsibilities include cash pooling, investments, financial risk management, capital allocation and corporate treasury initiatives. SUPERVISION RECEIVED The position is under the supervision of the VP, Treasurer ESSENTIAL DUTIES AND RESPONSIBILITIES To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Primary responsibilities are: * Management of cash and banking operations (includes pooling, structure, bank account services, bank relationships, etc.) * Monitor global cash position and ensure all legal entities have proper funding * Collaborate with Global Business Services and Tax in managing global cash forecast * Execute investing strategies and invest excess funds based on safety and preservation of principle in accordance with the company's investment policy * Develop and execute financing strategies and capital allocation strategies * Formulates, communicates, and supervises management of departmental policies and procedures * Execute and monitor risk management policies and procedures for interest rate risk and foreign exchange risk * Project management for Treasury strategic initiatives * Prepare and deliver presentations for Executive Management and the Board of Directors * Performs other related duties as assigned DESIRED MINIMUM QUALIFICATIONS The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. Education: Bachelor's Degree in Accounting or Finance Experience Required: * 7+ years experience in financial analysis, treasury management and cash management * Experience with international cash operations and treasury background * Excellent communication and organizational skills * Proven ability to work with a diverse group of people * Demonstrated focus on exceeding goals and results * Strong research, investigative and analytical skills TOOLS AND EQUIPMENT USED Ability to utilize a computer, fax, copier, telephone and other general office equipment. PHYSICAL REQUIREMENTS The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position. While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, type and move throughout the facility. Must be capable of using a keyboard for computer purposes. DISCLAIMER The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description is subject to change as the needs of the business and requirements of the position change #LI-NN1 Salary Pay Range: $166,750.00 - $228,850.00 USD Salary Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following ******************************************* Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at ***********************. Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails. Integra - Employer Branding from Integra LifeSciences on Vimeo
    $166.8k-228.9k yearly Auto-Apply 43d ago
  • Customer Service Manager (Philadelphia, PA)

    Philips Healthcare 4.7company rating

    Philadelphia, PA job

    Job TitleCustomer Service Manager (Philadelphia, PA) Job Description The Customer Service Manager Defines and implements service operations strategies, ensuring alignment with corporate objectives and driving excellence in service delivery across all business units. Your role: Provides inputs towards the development of advanced, scalable operational frameworks for new service offerings, ensuring these frameworks are integrated seamlessly with existing systems and can support future growth. Drives transformational changes in service operations by enforcing our service delivery plan that address complex operational challenges and deliver significant improvements in efficiency and effectiveness. Establishes and enforces rigorous standards for quality, compliance, and regulatory adherence across all service operations, ensuring that all processes meet the highest legal and operational requirements. Supports strategic account planning by contributing service insights and identifying new opportunities to enhance customer experience. Manage daily reports, run daily service team meetings, and attend hospital environment of care meetings. You're the right fit if: You've acquired 2+ years of experience in medical device service operations or biomedical engineering Your skills include experience working with or supporting Diagnostic Imaging or large healthcare systems. You have a Bachelor's OR Minimum 1+ years of experience with Master's in areas such as Service Delivery, Service Operations or equivalent. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. You've demonstrated experience managing cross-functional projects involving multiple stakeholders and departments. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is a field based role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details The pay range for this position in PA is $88,000 to $140,000 The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Philadelphia, PA. This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
    $88k-140k yearly Auto-Apply 51d ago
  • Senior Specialist, Regulatory Affairs

    Integra Lifesciences 4.8company rating

    Princeton, NJ job

    Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Senior Regulatory Affairs Specialist is a seasoned senior professional role responsible for contributing to and implementing regulatory strategies for the Company with a focus on achieving compliance for all current and upcoming regulations in the US, EU, Canada and globally. The Sr. Regulatory Affairs Specialist is responsible for providing advanced level regulatory input for regulatory documentation and development or sustaining projects to ensure that regulatory requirements are met. Responsibilities include analysis and review of data, resolution of complex regulatory issues, identification of gaps and maintenance/update of existing technical files and ensuring that new products are compliant to new requirements. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily: + Using a broad base of knowledge and understanding of regulatory requirements, will assume major responsibility for supporting new product development. + Utilizing an advanced base of knowledge and understanding of regulatory requirements, documentation, language, and the submission filing process to lead a focused team to ensure that the product portfolio and the required regulatory documentation is optimized for the business. + Provide regulatory input to cross-functional teams. Works independently to evaluate regulatory issues, develop and implement regulatory strategies, and revise technical documentation for existing and new regulatory submissions. + Lead in the development of US and International regulatory strategies and verification and validation activities for assigned product submissions. Author draft submissions (510k, PMA, BLA) with minimal supervision. + Ensure timeliness of regulatory submissions according to business needs. This includes ensuring prompt follow-up to the questions and requests received from regulators. Under minimal supervision, assist with the coordination, preparation, and maintenance of FDA PMA and BLA filings such as Annual Reports, 30 Day Notices, and 180 Day Submissions in accordance with US FDA requirements. + Interact with Regulatory Body personnel with minimal supervision. Actively lead the regulatory aspects of upcoming audits and certification reviews with all Company designated Notified Bodies. Communicate with the Company's Notified Bodies regarding regulatory issues/questions and schedule Technical Documentation/Technical File reviews. + Identify strategies to ensure compliance and maintenance of Regulatory Affairs product files (design dossiers, periodic regulatory reports) to support compliance with regulatory requirements. + Develop regulatory strategies around ad/promo reviews based on regulations; Review promotional and advertising material for adherence to approved product claims and regulatory compliance. + Serve as the RA lead and work in partnership with Product Development, Manufacturing and QA/QC to ensure overall compliance with US, Canadian, European, and International regulations. + Lead rollouts of product changes with corporate and international regulatory teams. + Lead Unique Device Identification system requirements and other labeling compliance of new products introduced into the market. Plan and coordinate rollouts of product changes with corporate and international regulatory teams. + Serve as RA lead and work with cross-functional management to review and approve rework of non-conforming product CAPA, SCAR, HHE and Field Actions. + Support product risk management in accordance with FDA/ISO 14971. Work independently or with minimal supervision to review complex Change Engineering Requests, Document Change Requests, Variances, and other Quality System Documentation that requires regulatory review and approval to ensure compliance with government regulations. + Work independently to contribute to establishing labeling requirements per regulations and review labeling that requires regulatory review and approval to ensure compliance with government regulations Problem solving: Apply company policies and procedures to resolve a variety of issues of increasing complexity; Provide solutions to a variety of problems of moderate to high complexity. Participate in and lead continuous improvement projects within Regulatory Affairs and throughout the organization, as assigned. + Contribute to the authoring of SOPs and train key personnel as needed. Perform other duties as assigned. **QUALIFICATIONS** The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. + Bachelor's degree in science, Engineering, Regulatory Affairs, or other technically related field. + Minimum of 3-5 years related experience in an FDA regulated industry such as Medical Devices, Biotech or Pharma (must have at least 2 years in Regulatory Affairs and the remaining years can be in a related field such as Product Development, Quality, Operations to contribute to total experience). Education or certification in lieu of relevant experience accepted when the requirements below are met: + RA Certification (RAC) can count towards 1 year of specific RA experience + Master's degree can count towards 2 years of relevant (non-RA) experience + Terminal degree (Doctorate or PhD in Business, Science, or related discipline) can count towards 4 years of relevant (non-RA) experience. + Experience in working effectively with cross-functional teams and provide regulatory input (e.g., manufacturing sites, new product development teams, marketing teams, quality teams). + Strong working knowledge of domestic and/or international medical device regulations including 510k, PMA, PMA Supplements,361 HCT/Ps, and international dossier submissions; Experience with medical device, biologic or implantable products is preferred, but not required. + Understanding and application of business strategies and tactics, including an understanding of regulatory impact. + Ability to effectively interface with multiple company disciples and responds to complex questions related regulatory requirements. + Must have proven ability to prepare and submit documents to regulatory agencies independently or with minimal supervision. + Ability to explain regulatory requirements and pitfalls to project teams and colleagues. + Can communicate existing facts in an organized and clear manner to cross-functional teams. + Must be detail oriented, well-organized, and able to work both independently and in teams. + Must possess and demonstrate an understanding of FDA requirements and quality system requirements. + Must have strong writing, project management and communication skills. + Demonstrated skills in contributing to multiple projects simultaneously. + Established skill in objective and critical thinking. + Develops proposals for solutions and applies solutions to identified issues. + Develops plans to meet pre-defined Regulatory goals. + Responsible for tasks and advanced submission components with ability to create templates when non exist. + Capability to interact with diplomacy and tact while maintaining appropriate assertiveness. + Willingness to take ownership and accept responsibility for actions and decisions. + Ability to communicate effectively in both informal and formal settings. + Regulatory Affairs Certification (RAC) is a plus and can be obtained on the job. Salary Pay Range: $81,650.00 - $112,700.00 USD Salary Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training **.** In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation **.** Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following ******************************************* Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law (********************* | EOE including Disability/Protected Veterans (******************************************************************** Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (************************************************** . If you have difficulty using our online system due to a disability and need an accommodation, please email us at ***********************. Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails. Integra - Employer Branding from Integra LifeSciences on Vimeo (*****************************************
    $81.7k-112.7k yearly 19d ago
  • Project Engineer / Senior Project Engineer

    Perkinelmer, Inc. 4.8company rating

    Perkinelmer, Inc. job in Trenton, NJ

    Responsibilities This is a fully onsite role with Project Farma, a PerkinElmer company Project Engineers(PE) and Senior Project Engineers(Senior PE) are fully billable roles that will work collaboratively with clients, vendors, contractors, and other Team Members to support projects related to biomanufacturing across the entire engineering lifecycle. PEs and Senior PEs are responsible for delivering high quality work, forming and maintaining valuable, long-term relationships with our clients, and continually strengthening their technical and industry knowledge. They will maintain a strong focus on Project Farma'sPatient FocusedandPeople Firstmindset. Key Responsibilities Site Strategy * Support the execution of site strategy under the direction of the Site Lead, contributing to specific project tasks that align with Project Farma's services. * Perform assigned tasks to meet strategic objectives, such as preparing and executing CQV Protocols * Identify and reports client needs or project challenges to the Site Lead for further action. * Maintain professional relationships with project team members and client POCs at the operational level (e.g., technicians, engineers) to facilitate task completion. Business Growth & Development * Contribute to project-level success by delivering high-quality work that supports business growth opportunities. * Provides data or insights (e.g., project progress, risks) to the Site Lead for inclusion in dashboards or expansion discussions. * Participate in project tasks that support extensions or proposals, such as preparing deliverables for clients. * Build meaningful internal and external relationships. * Present Project Farma as a service to clients as needed. * Communicate with clients in a professional manner. * Ensure any client feedback or opportunities identified are being escalated properly. Talent Development * Focus on professional development and support team collaboration under the Site Leads guidance. * Share technical knowledge with peers to support project delivery. Resource Management * Provide input on task-level resource needs to the Site Lead to support project delivery. * Report workload or skill gaps within assigned tasks. * Assist in maintaining project schedules by communicating resource constraints. Technical Delivery * Create alignment with cross-functional client departments including but not limited to Validation, Manufacturing, Quality, Supply Chain, Engineering and Project Controls * Communicate updates internally in a timely manner and relay in-field project decisions to highlight long-range, down-stream project and team impacts. * Provide hands-on support and troubleshooting for clients navigating the engineering life cycle of cutting-edge equipment and manufacturing processes. * Perform due diligence on system and subject domains to generate high-quality project deliverables. * Execute specific technical tasks within a project, ensuring high-quality deliverables. * Perform CQV tasks, such as protocol development or equipment testing, under the Site Lead's guidance. * Report technical issues to the Site Lead and support resolution efforts. * Ensure tasks meet client specifications, regulatory requirements (e.g., FDA, GMP), and industry standards. * Author technical documents: SOPs, requirements specifications, testing protocols, summary reports, etc. * Identify and close individual knowledge gaps with support from other team members or leads as needed. * Execute system and process validation protocols by using GxP best practices. * Proactively identify and escalate roadblocks and utilize critical thinking skills and knowledge of problem- solving skills to identify creative solutions to those problems and roadblocks. * Support necessary billables as forecasted by site dashboards on billable targets per month. * Maintain internal site tools such as site dashboards, deliverable trackers, etc. * Continually develop technical aptitude of Project Farma's core services within the life science space including but not limited to: Capital Project Management, Facility Builds, Tech Transfers, Validation Life Cycles including CQV and Computer system Validation, Quality, Regulatory and Compliance, GxP Automated Systems, and Quality Control including clinical and commercial. * General understanding of Earned Value Analysis (EVA) and PO management tool * Analyze complex project data and then deliver clear, articulate and concise messages in a compelling manner to support decision making. * May be requested to assist with Project Controls and Scheduling to include; Budget estimates, detailed project schedules and milestones, feasibility estimates, risks, forecasts and scenario analysis and project cost reports and analysis. Operational Performance & Billability * Maintain 100% individual billability by completing assigned project tasks. * Escalate any roadblocks on achieving billable targets to the site lead. Experience Required * 0-4 years' experience in consulting and/or engineering services. * Bachelor's Degree in Life Science, Engineering, or related discipline (OR a combination of equivalent work experience in CQV engineering, cGMP facility start-up, project management and/or comparable military experience). Other Required * Full-time on-site client presence * Willingness to travel up to 100% or as required. Applicants must be authorized to work in the United States on a full-time basis. We will not sponsor applicants for current or future work visas for this position. This position may require significant travel to support project and business needs. We cannot employ anyone with an invalid driver's license.
    $97k-119k yearly est. 23d ago
  • Supervisor, Production - Weekend (Friday - Sunday)

    Integra Lifesciences 4.8company rating

    Plainsboro, NJ job

    Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. **SUMMARY DESCRIPTION** The Supervisor, Packaging Operations is responsible for the skin packaging production activities for CMC (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality of our medical devices. This includes assigning and monitoring weekend (Friday through Sunday) first shift activities of production staff and partnering with other support departments to efficiently and compliantly complete work and work processes as per outlined production schedules. All production is to be conducted in compliance with ISO 7 and ISO 5 Clean Rooms and with Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP's), and Health and Safety requirements. This job is expected to work onsite. This is a weekend-12 hours first shift from Friday through Sunday. **SUPERVISION RECEIVED** Under direct supervision of the Senior Manager, Manufacturing. **SUPERVISION EXERCISED** Directly supervises weekend first shift manufacturing cleanroom operators and lead operators. **ESSENTIAL DUTIES AND RESPONSIBILITIES** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. + Ensures thorough behavior and action a safe working environment for all employees. + Facilitates teamwork and cooperation with a focus on developing a Lean culture, with the ultimate goal of a high level of employee engagement and customer satisfaction. + Ensures all established costs, quality, and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. + Responsible for the overall direction, coordination, and evaluation of the manufacturing area, overseeing all production activities to ensure that all Standard Operating Procedures (SOPs) are properly followed. + Provides daily coaching and development to their direct reports. + Reviews production and operating reports and participates in the resolution of operational, manufacturing, and maintenance problems to ensure minimum costs, prevent operational delays, and maintain quality and regulatory compliance standards. + Trains and ensures all assigned employees are aware of and comply with company, government procedures, and regulations. + Partners with other functions such as Facilities, Maintenance, Engineering, Quality, Warehouse, and Planning groups to ensure a seamless flow of activities across and during the shift. + Participates in investigative teams to resolve ongoing issues including failure investigations. Perform investigations as they pertain to the manufacturing realm of responsibilities. + Reports any non-conformances in a timely manner. + Works closely with the quality department to coordinate the generation, and processing of non-conformances (NC), Corrective Preventive Action Plans (CAPA), and audit observations in a timely manner. + Pass and maintain gowning qualification for ISO 5 and ISO 7 Clean rooms. + Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance and managing employee performance, addressing complaints, and resolving problems. + May also perform other related duties, responsibilities, and special projects as assigned. **DESIRED MINIMUM QUALIFICATIONS** + Bachelor's degree or higher in Science, Engineering, or related fields is desired. + 3+ years of relevant leadership experience in a GMP regulated industry. + Knowledge of NCs and CAPAs. + Must have strong written and verbal communication skills. Must possess strong leadership skills with team-focused attitude and approach. + Must be able to gown into ISO 7 and ISO 5 Clean Room gowning. + Batch manufacturing experience. + Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, and other National and International regulations and standards. + Strong computer skills, including Microsoft Office experience required. + Knowledge of Oracle R12/Agile preferred. + Understanding of Lean/six Sigma a plus. TOOLS AND EQUIPMENT USED General office equipment including but not limited to computer, telephone, and copier. PHYSICAL REQUIREMENTS The physical requirements listed in this section include but are not limited to the motor/physical abilities and skills required for this position. In order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position. While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, and write/type. The employee is required to go to all areas of the company, including the manufacturing cleanrooms. The employee may be required to periodically lift 25 lbs. The employee may be required to stand for prolonged periods of time. ADVERSE WORKING CONDITIONS The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment. Adverse exposure may result from the handling of hazardous and biohazardous materials that include, but are not limited to, flammable and corrosive liquids, compressed gases, sharps, and medical wastes. DISCLAIMER The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change. Salary Pay Range: $81,650.00 - $112,700.00 USD Salary Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training **.** In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation **.** Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following ******************************************* Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law (********************* | EOE including Disability/Protected Veterans (******************************************************************** Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (************************************************** . If you have difficulty using our online system due to a disability and need an accommodation, please email us at ***********************. Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails. Integra - Employer Branding from Integra LifeSciences on Vimeo (*****************************************
    $81.7k-112.7k yearly 60d+ ago
  • Sr Refrigeration Maintenance Technician

    Integra Lifesciences 4.8company rating

    Plainsboro, NJ job

    Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The **Senior Refrigeration Technician** , reporting to the Maintenance Supervisor, this position is responsible for operating, maintaining, troubleshooting and repairing process refrigeration, mechanical systems and equipment such as Lyophilizers, HVAC equipment, fume hoods, exhaust fans, air handlers and distribution systems related to manufacturing and utility equipment in a cGMP medical device manufacturing plant. Such equipment may include but is not limited to: + Manufacturing Process Equipment (Autoclave Sterilizers, Mills, Mixers, Sealers, Washers) + Facility Equipment (Clean Compressed Air, Heating Hot Water, Clean Steam, Plant Steam, Waste + Treatment, WFI Generation) + Refrigeration Equipment (Freezers, Industrial Chillers, HVAC, Lyophilizer, Refrigerators) **This is a first shift role. (7:00 a.m. - 3:30 p.m.) Monday to Friday** **Rate for this role is in the $40 - $50 per hour range depending upon experience.** **ESSENTIAL DUTIES AND RESPONSIBILITIES** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. + Responsible for the repair and maintenance of industrial refrigeration equipment associated with HVAC, freeze dryers/lyophilizers, chillers, and other related plant equipment. + Responsible for compliance to Catastrophic Ozone Depletion regulations, specifically the inventory of all refrigerant use and the repair of leaks in equipment or systems on a timely basis. + Responsible for the operation and maintenance of the Water for Injection and Pure Steam Generator systems, including storage and distribution systems. + Responsible for the operation and maintenance of the compressed air systems, both plant and clean compressed air. + Responsible for maintaining up to date preventative maintenance records on all equipment and related electrical system components. + Responsible for providing technical instruction, coaching, and guidance to other technicians and contractors, as required, during the execution of refrigeration-related tasks. + Responsible for the completing all Corrective Maintenance Work orders accurately and using Good Documentation Practices. **DESIRED MINIMUM QUALIFICATIONS** The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. + Certificate from a Vocational, Trade School or military equivalent + 5+ years' experience in a maintenance position with responsibility for maintenance and operation of process refrigeration equipment and HVAC systems, preferably in the medical device or pharmaceutical industry. + Must possess a Refrigerant CV 1&2 license + PLC (Programmable Logic Computer) experience preferred + Computer Literate + Valid New Jersey Driver's License; use of personal vehicle may be required + Experience with CMMS software. + Knowledge of troubleshooting electrical and instrumentation systems. **ADDITIONAL INFORMATION** + Willing to perform other related tasks. + Knows location of all shop equipment and supplies. + Able to work with minimal supervision. + Able to start, stop, and operate all equipment. + Willing to be on an emergency standby schedule as created by the Maintenance Manager, to handle emergency calls at all Integra facilities. + Must be available for overtime in emergency situations, and work flexible hours to provide coverage. **TOOLS AND EQUIPMENT USED** Hand and power tools, meters and other diagnostic equipment **PHYSICAL REQUIREMENTS** The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position in to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position. While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, occasionally bend, stoop, and crawl, and move to all areas of the facility. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 50lbs. Salary Pay Range: $29.86 - $40.91 USD Hourly Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training **.** In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation **.** Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following ******************************************* Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law (********************* | EOE including Disability/Protected Veterans (******************************************************************** Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (************************************************** . If you have difficulty using our online system due to a disability and need an accommodation, please email us at ***********************. Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails. Integra - Employer Branding from Integra LifeSciences on Vimeo (*****************************************
    $40-50 hourly 60d+ ago
  • Hospital Customer Project Manager - Northern NJ

    Philips Healthcare 4.7company rating

    New Brunswick, NJ job

    Job TitleHospital Customer Project Manager - Northern NJJob DescriptionServe the healthcare community through effective and efficient management of capital medical equipment installations and IT solution implementation at various stages across the healthcare continuum for the Philips Healthcare Services and Solutions Delivery (S&SD) business. Your role: Your role as a Customer Project Manager (CPM) will be to manage multiple implementations that vary in scope, size and complexity. Projects can include IT solutions, capital equipment installation and systems integration. You will ensure a stellar customer experience guided by the statement of work. Coordinating, leading and motivating a diverse cross-functional team of internal and external Sales, Clinical and Technical resources in coordination with the hospital provided project manager or point(s) of contact. Ensure site readiness and adherence to project timelines. Advises on project plan and responsible for daily updates on project status and activities. This is a field-based position with travel up to 75% of the time within the District, covering New Brunswick, NJ. The applicable PMI certification per role/level is required for all Employees hired/re-hired into the CPM/CDM role (including internal transfers from a non-CPM/CDM role). PMI certification obtainment is required within a specific time period of an employee's start date in the CPM/CDM role. This time period is defined by the role/level and will be documented in the employment offer. You're the right fit if: You've acquired a minimum 5 years of experience in Project Management and IT Integration within a Healthcare Environment preferred (i.e. Healthcare Information Technology, Patient Monitoring, Telemetry, Nursing Informatics) You have a Bachelor's degree in the areas of: Clinical or Computer Science, Information Technology, Project Management or equivalent. You have robust leadership skills, paired with the ability to influence across all project resources/stakeholders. Excellent interpersonal and communication (verbal and written) skills. Company relocation benefits will not be provided for this position. For this position, you must reside in or within the Northern NJ area and travel up to 75% in the market. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is a Field role in the New Jersey market. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details The pay range for this position in NJ is $99,000 to $157,000. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to New Brunswick, NJ. #LI-PH1 This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
    $99k-157k yearly Auto-Apply 21d ago
  • Validation Engineer II

    Integra Lifesciences 4.8company rating

    Plainsboro, NJ job

    Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. Responsibilities associated with this position are directly associated with the introduction and launching of new equipment or products and processes into a manufacturing facility. The candidate must utilize problem solving techniques to resolve issues and conflict in order to meet the high level goals set forth by the organization. The candidate must be well organized and technically sound in understanding scientific rationale and justifying criterion from a quantitative standpoint. The candidate must be familiar with process flow of a medical device organization, including the regulatory impact of change and the documentation path of a compliant process. The candidate must possess technical writing experience in protocol generation and procedure generation. Some experience is required in master plan generation and the change control life cycle. The candidate must be a team player who thrives in a team environment, but also has the capability to work on their own to research and investigate. Gown qualification is a plus, with an understanding of clean room practice and cGMP environments. The qualified candidate must understand the concepts of risk management and the ability to identify and classify critical parameters within a production setting. To perform this job successfully, an individual must be able to perform each essential duty Satisfactorily: + Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation. + Must be able to read and understand engineering P&ID's and turnover documentation. + Work with project teams to develop DOEs and statistically sound tests for appropriate support of results. + Complete test method validation, gauge r&r studies and other qualifications or studies to support product testing. + Scheduling coordination, material allocation and alignment of personnel in order to successfully complete validation assignments. + Develop statistically based sampling plans for in-process and final test sequencing. + Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements. + Support and address comments and suggestions associated with validation and engineering documentation. + Protocol, Deviation, and summary report generation and approval. + Change control, non-conformance and CAPA support. + Participate in FDA inspections, ISO certifications, surveillance audits and customer audits. **QUALIFICATIONS** The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. + Bachelors Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry). + 2 to 6 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical environment. + Demonstrates excellent organizational and communication skills. + Experience with qualifying medical device manufacturing equipment. + Results oriented with a strong focus on quality principles and conflict resolution. + Excellent technical writing skills with a thorough understanding of good documentation practices. + Experience using temperature mapping equipment including Kaye Validators and Valprobes preferred. + Competent in tracking and updating schedules to provide upper management visibility of milestones and achievements. Salary Pay Range: $71,300.00 - $97,750.00 USD Salary Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training **.** In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation **.** Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following ******************************************* Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law (********************* | EOE including Disability/Protected Veterans (******************************************************************** Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (************************************************** . If you have difficulty using our online system due to a disability and need an accommodation, please email us at ***********************. Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails. Integra - Employer Branding from Integra LifeSciences on Vimeo (*****************************************
    $71.3k-97.8k yearly 60d+ ago
  • Quality Control Inspector II

    Integra Lifesciences 4.8company rating

    Plainsboro, NJ job

    Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The **Quality Inspector II** will be responsible for performing quality assurance inspections on purchased components, manufactured sub-assemblies and final product. The Quality Inspector will perform all duties in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies. Expectations are to be familiar with and able to measure critical dimensions. **ESSENTIAL DUTIES AND RESPONSIBILITIES** + Perform inspection by using a variety of inspection measuring and test equipment to determine acceptance or rejection of material or parts. + Perform first article, incoming/receiving, and in-process inspections of materials or parts; determine acceptance or rejection after inspection and/or testing of materials, parts, and/or equipment. + Interpret and work within the guideline of drawings, specifications, charts, procedures, and other data to determine acceptance or rejection of materials. + Read and interpret sampling pan as per the American national standard institute (ANSI), + Assist in the review and disposition of non-conforming material and customer returned material, including rework, scrap, and return to vendor. + Maintain accurate and current inspection and/or testing records such as nit not limited to Material Certifications, Inspection/Test Results and reports, Certificates of Conformance, Rejection reports/tags, as required by applicable procedure and/or specification. + Coordinate and inform other departments of inspection and/or testing status in support of production and project goals and initiatives. + Promote and participate in continuous improvement initiatives. + Responsible for the maintenance of appropriate conditions of all quarantine locations. + Maintain the QC inspection areas in an orderly fashion conducive to carrying out safe and efficient inspections and procedures. + Inspection requirements include training and working in classified clean rooms as necessary to perform in process inspections. + Maintain records of inspection and all testing performed on the appropriate test records. + Perform line clearances and quality reviews in manufacturing, labeling, or other assigned areas during manufacturing activities. + Identify and implement opportunities for continuous improvement, including document revisions in order to maintain accurate SOPs. + Provide quality support to various departments as needed, e.g. engineering, product development, etc.) + Assist in training new associates according to the Quality System Regulations and company SOPs as applicable. + May also perform other related duties, responsibilities, and special projects as assigned. **DESIRED MINIMUM QUALIFICATIONS** + Associate degree in science is preferred. + 3-7 years of relevant GMP/GLP experience specific to incoming, line clearance, in-process, and finished goods inspections in pharmaceutical or medical device industry. + QA experience in the medical device industry preferred. + Must have strong written and verbal communication skills. + Strong organizational skills, self-directed, strong problem solving and interpersonal skills. + Knowledge of CAPA, Validations, Change Control, preferred. + Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP. + Knowledgeable in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) preferred. Salary Pay Range: $21.12 - $27.98 USD Hourly Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training **.** In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation **.** Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following ******************************************* Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law (********************* | EOE including Disability/Protected Veterans (******************************************************************** Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (************************************************** . If you have difficulty using our online system due to a disability and need an accommodation, please email us at ***********************. Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails. Integra - Employer Branding from Integra LifeSciences on Vimeo (*****************************************
    $21.1-28 hourly 28d ago
  • Export Trade Compliance Specialist

    Integra Lifesciences 4.8company rating

    Princeton, NJ job

    Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The **Export Trade Compliance Specialist** plays a critical role in ensuring full compliance with U.S. Customs and Border Protection (CBP), FDA, and other government agency regulations for both imports and exports. This position's focus will be classification and Country of Origin validation, and is responsible for validating, maintaining, and updating tariff codes (HTS and Schedule B), The specialist also supports broader trade compliance activities, including sanctioned-country screening, documentation for export shipments, and acquisition-related trade compliance integration. This person will also need to have a working understanding of Export Administration Regulations (EAR), U.S. laws managed by the Bureau of Industry and Security (BIS) that control the export/re-export of commercial goods. This person will assist our global offices as needed. This person will be working to improve compliance and assist with implementing best business practices. **RESPONSIBILITIES** + Designate Global customs classifications (HTS, Sch B & ECCN) of all products imported or exported, for US and European Compliance Team + Working understanding of Export Administration Regulations (EAR) + Assist Global Transportation team as needed + Assist with Compliance Projects as assigned + Assist in internal Export/import audits as assigned + Extract, proof, analyze and update import/export data components, as necessary + Support and assist with CDOP/ECO approval for Trade Compliance department + Dedicated assistance in country-of-origin validation + Assist Manager and Team with trade sanctioned country due diligence and sanctioned party screenings + Assist Manager and Team with daily import/export processes, including, but not limited to, Export Electronic Invoice (EEI) filings, Creating Shipper's Letter of Intent (SLI), Free Trade Agreement Validations, and End User Agreements + Support and assist with global classification of all Integra commodities + Ensure compliance with all US government agencies relating to import & export + Assist with maintenance of import/export programs. + Monitor regulatory changes affecting import and export regulations, and surface adjustments to business procedures accordingly + Perform other related duties as assigned + This position may require occasional travel to Integra locations, not to exceed 10% annually. **DESIRED MINIMUM QUALIFICATIONS** + Minimum of three (3) years of experience in Import/Export Customs Compliance, with practical knowledge of international trade and export regulations. + Proficiency with US Harmonized Tariff Codes, Global Harmonized Tariff Codes and Export Control Classifications + Working understanding of Export Administration Regulations (EAR) + Working knowledge of Enterprise Resource Planning (ERP) system, Oracle preferred + Working understanding of Sanction Party Screening tools, Descartes, Kharon, or Securimate preferred + Excellent verbal and written communication skills with proficiency in English + U.S. Customs Broker License is a plus, but not essential for consideration + Proficiency in MS Excel, Word, Power Point + Strongly preferred but not required: experience in a multinational manufacturing and distribution company, especially within the medical device or pharmaceutical industry Salary Pay Range: $71,300.00 - $97,750.00 USD Salary Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training **.** In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation **.** Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following ******************************************* Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law (********************* | EOE including Disability/Protected Veterans (******************************************************************** Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (************************************************** . If you have difficulty using our online system due to a disability and need an accommodation, please email us at ***********************. Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails. Integra - Employer Branding from Integra LifeSciences on Vimeo (*****************************************
    $71.3k-97.8k yearly 19d ago
  • Category Manager, Indirect Goods & Services, Facilities Services

    Integra Lifesciences 4.8company rating

    Princeton, NJ job

    Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Category Manager, Indirect Goods & Services, - Facilities Services is responsible for the coordination and development of category plans, strategies, vision, process efficiency, strategic sourcing initiatives and tactics withing the Facilities Services category. Overall spending responsibility will be approximately $100M and savings targets will be set annually by the global procurement organization. The Category Manager will interact with key business stakeholders to assist in driving category specific strategies to support those business objectives. Will also be responsible to manage and coordinate the supplier relationship and performance evaluation process for the responsible categories. Under the direction of the Director of Indirect Goods & Services, Global Procurement, this role will create a Facilities Services model. Within this model, the Senior Category Manager will manage the identification, implementation and alignment of sourcing strategies and supplier capabilities for various categories of spend. Develop and manage strategic business relationships and gain a comprehensive understanding of business requirements to ensure stakeholder objectives are in alignment with sourcing strategies. Identify metrics, tools, and processes to optimize sourcing, supplier activities and efficiencies and work collaboratively with team members to prioritize and drive implementation. **ESSENTIAL DUTIES AND RESPONSIBILITIES** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Primary Responsibilities: + Ensure compliance with company and division-wide purchasing/procurement strategies, policies, standards, and practices. + Stakeholder Management: Effectively document, communicate, and gain support for the strategies from local executive leadership, and global procurement organization. Provides analysis and recommendations to management on financial decisions surrounding sourcing issues. Prepare supplier recommendations for decision-making, including global procurement and Executive Committee recommendations. + Category Strategy/Sourcing Plan: Develops short-term and long-term category specific strategies that align with the Company goals for reducing costs and meeting financial expectations, while managing supplier relationships. Drive consolidation of spend and seek out synergies across all sites where applicable, by forming and leading cross-functional strategic sourcing teams to develop and implement category/commodity strategies and to drive cost from individual spend sub-categories; consults with Sr. Management, and other subject matter experts to develop alternative solutions; advises on options, risks, total cost of ownership, and business impacts. + Project Management: Executes category sourcing strategies including development and execution of RFI's and RFP's, documents bid events through correspondence to suppliers; develops selection criteria and drives the selection and approval process of suppliers in collaboration with cross-functional teams; conducts supplier negotiations and ongoing supplier management. Develop negotiation strategies, gain alignment from stakeholders, lead cross-functional, category-based negotiation teams, and implement appropriate supplier risk analysis. Actively seeks ways to streamline business processes; researches and provides information on industry category trends and best practices. Provide procurement input to maximize procurement leverage, optimize project design and minimize project durations and cost. Researches the market for new and alternative ideas, suppliers, processes, and products to improve efficiency and profitability. Analyzes marketing information and production assumptions, forecast plans for anticipated materials requirements. Evaluates and selects suppliers, including foreign sourcing. + Contract Management/Metrics: Manage contracts, contract negotiation, and contractual dispute resolutions. Pre-negotiate and incorporate terms, conditions, key performance indicators, and service level metrics into supplier contracts. Participate in negotiations of major contracts and blanket purchase agreements with critical suppliers for goods and services, together with the Law Department and business areas. + Trusted Advisor: Ensure business process efficiency, and process improvement in line with Procurement strategy to empower the business as strategic partners. + Supplier Relationship Management: Interacts with stakeholders to develop, engage, and lead supplier relationships for extracting the greatest value in supplier quality, total cost effectiveness, enhanced service levels, risk management, sustainability, and innovation. Manage the ongoing performance of our suppliers including objective setting and supplier evaluations where warranted. Establish and lead effective network with suppliers and internal customers. Manages ongoing relationships with key strategic suppliers and the manufacturing and headquarters sites. Works with suppliers to continuously improve the value of goods and services provided with added focus on quality, responsiveness, and delivery. Ensure continuity of supply of purchased goods and services. **DESIRED MINIMUM QUALIFICATIONS** The requirements listed below are representative of the knowledge, skill and/or ability required for his position. Education: + Degree in Supply Chain Management, Operations, Engineering, Business, or a related discipline + 5 - 10 years' experience in procurement management or equivalency Certifications: + Lean or Six Sigma certification is preferred + CPSM, PMA and/or APICS Certification is preferred + Advanced Degree Preferred but not required **SKILLS AND COMPETENCIES** Skills: + Commercial awareness beyond Procurement + Strong quantitative, cost modeling, and data analysis skills + Strong Supplier Relationship Management skills + Strong project management and process improvement skills + Experience with complex contract negotiations and subcontracting of labor work + Experience with developing Facilities Services category strategies + Development of stakeholder engagement + Strong communication and presentation skills + Excellent negotiation, interpersonal, and leadership skills + Change agent with ability to influence at all levels of the organization + Problem solving experience in reducing total costs, improving processes, and reducing supplier risk + Advanced knowledge of SAP, P2P Suites, and Microsoft Suite (especially Excel). Competencies: + Operates with minimal business direction + Demonstrated knowledge and experience in procurement processes and driving business results through influence and leadership. + Flexible and able to adapt to immediate business area needs and timelines + Professionalism + Negotiation + Initiative + Communication (Oral and Written) + Relationship Management + Consultative Selling Skills Experience: + Medical Device or Pharmaceutical industry experience is preferred + Overseeing strategic planning and execution regarding end-to-end facility operations + Integrated Facilities Management experience with both office and manufacturing sites, GMP and Medical Device/Pharma experience preferred + Subject matter expertise in corporate facility management, contract negotiations, building management, construction project administration + Excellent business acumen, including demonstrated abilities and leadership with financial analyses, business case preparation, NPV, ROI, and data-driven approach + Ability to oversee strategic planning and execution + Sourcing of facilities services and maintenance suppliers + Experience in managing supply base and building relationships with external partners + High level of proficiency using Microsoft Office Suite Excel, Power Point, Word and Outlook. + Working knowledge and experience with ERP systems required - preference to those with Oracle ERP and Cognos experience. + Forecasting, planning, purchasing, negotiating, and budgeting abilities + Ability to work effectively with a variety of cultures, people, styles, and personalities across multiple sites without direct supervision + Experience in leading cross-functional teams and project management + Excellent verbal and written communication skills + Must be able to read and write in English. Must be able to demonstrate comprehension of written English by successfully completing unassisted written tests, including but not limited to, Work Instructions and Standard Operating Procedures + Experience with the details of legal contracts + Must be able to give and welcome constructive feedback; contribute to building a positive team spirit. + Must treat others with respect, work with integrity and ethically uphold organizational values. **Additional Information:** This is a hybrid role, and the ideal candidate will be based out of Princeton, NJ. The hybrid schedule requires in-office presence on Tuesdays, Wednesdays, and Thursdays, with the option to work remotely on Mondays and Fridays. Salary Pay Range: $109,250.00 - $149,500.00 USD Salary Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training **.** In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation **.** Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following ******************************************* Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law (********************* | EOE including Disability/Protected Veterans (******************************************************************** Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (************************************************** . If you have difficulty using our online system due to a disability and need an accommodation, please email us at ***********************. Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails. Integra - Employer Branding from Integra LifeSciences on Vimeo (*****************************************
    $109.3k-149.5k yearly 35d ago
  • Senior Process Engineer II - Endotoxin

    Integra Lifesciences 4.8company rating

    Princeton, NJ job

    Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. **SUMMARY** We are seeking a highly skilled and motivated Senior Process Engineer II with a focus on bacterial endotoxin testing programs in the medical device industry. The successful candidate will be responsible for partnering with bacterial endotoxin Subject Matter Experts to interpret and translate requirements into compliant and harmonized systems and procedures. This role requires a strong process-engineering mindset, a willingness to learn about bacterial endotoxin testing programs, an understanding of medical device quality systems, and a commitment to ensuring product safety and compliance. The candidate must be a senior-level professional/team player with advanced process engineering knowledge and a propensity to lead successful teams. An understanding of bacterial endotoxin testing programs is preferred. The qualified candidate must understand the concepts of risk management as it relates to bacterial endotoxin monitoring in a medical device manufacturing environment. **RESPONSIBILITIES** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily: **Team Leadership & Development:** + Lead, listen to, and manage a team of subject matter experts responsible for implementing and optimizing bacterial endotoxin control programs in medical device manufacturing. + Foster a collaborative environment by promoting knowledge sharing, training, and professional growth within the team. + Manage team performance and set clear objectives to ensure that all goals are met efficiently and in compliance with industry standards. + Support the Environmental Controls Senior Manager with providing direction to the team, coordinating workflow, and providing guidance in the resolution of problems or areas of concern **Bacterial Endotoxin Process Oversight:** + Translate SME knowledge to manage the development, implementation, and validation of bacterial endotoxin control programs, ensuring compliance with relevant regulatory requirements such as ANSI/AAMI ST72, ISO 11737-3, USP , USP , and FDA guidelines. + Ensure proper integration of endotoxin testing within the overall product lifecycle, from early-stage development through manufacturing, packaging, and final product release. **Collaboration & Cross-Functional Support:** + Work closely with quality assurance and production teams to integrate endotoxin control practices within broader quality systems and manufacturing processes. + Collaborate with the sterilization and contamination control teams to ensure endotoxin levels are considered and controlled throughout the product lifecycle. **Risk Management & Safety:** + Lead risk assessments related to endotoxin control, identifying potential sources of contamination and implementing strategies to mitigate risks. + Ensure that endotoxin testing and control programs are aligned with broader risk management processes in the company, addressing endotoxin-related risks from both a product and patient safety perspective. **Regulatory Compliance & Documentation:** + Ensure thorough documentation and records related to contamination control, including process flow diagrams, standard operating procedures, and endotoxin program management tools. + Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements. **DESIRED MINIMUM QUALIFICATIONS** The requirements listed below are representative of the knowledge, skill, and/or ability required for this position + Bachelor degree with 8+ years of experience or equivalent education and years of experience + Master degree with 5+ years of experience or equivalent education and years of experience + Doctoral degree with 3+ years of experience or equivalent education and years of experience + Bachelor's or Master of Science degree in Industrial Engineering, Biomedical Engineering or similar discipline. + Minimum of 3-5 years of experience in process engineering + Demonstrates excellent leadership and organizational skills. + Excellent process mapping skills with an understanding of good documentation practice. + Strong written and verbal communication skills. + Proven ability to lead a team, manage multiple projects, and work cross-functionally. + Detail-oriented with a commitment to maintaining high-quality standards and regulatory compliance. + Experience with quality management systems (QMS) and CAPA processes. **Preferred Skills:** + Familiarity with bacterial endotoxin control methods, including LAL (Limulus Amebocyte Lysate) testing, recombinant Factor C assay, and endotoxin limit specifications. + Experience creating and changing procedures used in operations for testing of the environment and products. + Awareness of applicable endotoxin standards including, but not limited to, ANSI/AAMI ST72, ISO 11737-1, USP , USP , and FDA guidelines. TOOLS AND EQUIPMENT USED + Knowledge of Visio and other process improvement tools required. Salary Pay Range: $94,300.00 - $129,950.00 USD Salary Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training **.** In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation **.** Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following ******************************************* Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law (********************* | EOE including Disability/Protected Veterans (******************************************************************** Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (************************************************** . If you have difficulty using our online system due to a disability and need an accommodation, please email us at ***********************. Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails. Integra - Employer Branding from Integra LifeSciences on Vimeo (*****************************************
    $94.3k-130k yearly 60d+ ago
  • Specialist, Quality Compliance

    Integra Lifesciences 4.8company rating

    Plainsboro, NJ job

    Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The **Quality Compliance Specialist** will provide quality compliance support to the Collagen Manufacturing Center (CMC) Plant. This function shall participate in the development, review and/or approval of various Quality System Documentation to ensure that the development, manufacture and distribution of medical products are in compliance with company policies and procedures, US. Food and Drug Administration Regulations, ISO 9001, ISO 13485:2016 Standard, European Medical Device Directives, Canadian Medical Device Regulations, and other applicable regulatory agencies. Experience with assessing quality suppliers and purchasing specifications is a plus. **Having Quality Compliance experience with the Medical Device industry is a requirement of this role.** **ESSENTIAL DUTIES AND RESPONSIBILITIES** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Would be very beneficial to have the experiences below within the medical device industry. + Review and approve quality documents requiring QA oversight (e.g., IOPQ and validation protocols, Engineering Change Orders (ECO), deviations, OOS/OOT reports, DHR, Supplier Quality Assessments, Supplier Corrective Action Reports (SCAR), alert and action reports, purchasing specifications, etc.) + Prepare and compile metrics for Quality Management Reviews + Serve as the quality compliance representative for project teams + Participate on new product development project teams as quality compliance representative + Support investigation of complaints, nonconforming raw materials, in-process product or finished goods as necessary + Provide guidance for Product Development, Operations and Engineering teams on project development activities to ensure they conform to internal SOPs + Identify and implement opportunities for continuous improvement, including document revisions in order to maintain accurate SOPs. + Review product and process changes for impact on existing notification requirements, for conformance with Design Control regulations and standards, and internal Standard Operating Procedures + Provide support in FDA inspections, ISO audits and customer audits at the CMC facility **DESIRED MINIMUM QUALIFICATIONS** The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. + Bachelor's degree or higher in scientific, or related field. + 3- 5 years experience in Quality. + Excellent oral, written and presentation communication skills are required. + High degree of attention to details and organization skills are required + Must possess a team-focused attitude + Demonstrated computer skills. + Ability to work independently. Salary Pay Range: $71,300.00 - $97,750.00 USD Salary Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training **.** In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation **.** Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following ******************************************* Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law (********************* | EOE including Disability/Protected Veterans (******************************************************************** Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (************************************************** . If you have difficulty using our online system due to a disability and need an accommodation, please email us at ***********************. Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails. Integra - Employer Branding from Integra LifeSciences on Vimeo (*****************************************
    $71.3k-97.8k yearly 60d+ ago
  • Talent Management Culture & Engagement Manager

    Integra Lifesciences Holdings Corp 4.8company rating

    Princeton, NJ job

    Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Talent Management Culture and Engagement Manager will lead enterprise-wide initiatives focused on employee listening, engagement, culture, belonging and value proposition in support of Integra's people strategy and in alignment with business transformation. Employee Listening and Engagement * Develop and lead engagement strategies aligned with business and cultural goals * Partner with internal stakeholders and HRBPs to manage the deployment, analysis, and feedback cycle for employee surveys and engagement pulse checks * Plan, coordinate, and execute the organizational employee engagement action plans and associated activities * Develop and maintain project timelines, communications plans, and post-event metrics Culture and Belonging * Support the design and implementation of key HR initiatives that build a high-performing workforce and foster a positive, productive and engaging workplace culture * Translate content from internal listening sessions into strategic people and culture interventions * Advise on ways to make the company people practices more inclusive, enabling us to attract and retain talent and foster an environment of belonging Business Resources Groups * Drive BRG strategy execution, provide program oversight and prepare relevant internal communications * Serve as a coach to BRG leaders and executive sponsors * Utilize BRG insights to recommend internal program and process improvements * Stay current on inclusion trends, research, best practices and the evolving legislative climate. Advise on strategies to drive innovation and effectiveness. Employee Value Proposition * Coordinate the development of a compelling Employee Value Proposition (EVP) to attract, develop, and retain talent in collaboration with HR CoE Leads to bring together areas of expertise * Working with HR Leadership, develop ideas for the design of programs, projects and processes across the employee lifecycle that position the company as a competitive employer of choice Other * Manage vendor relationships and functional budget as needed * Set business-driven KPIs for culture, engagement and belonging focusing on organizational impact * Track and report key program success metrics DESIRED MINIMUM QUALIFICATIONS * Bachelor's degree in Human Resources or related field. Master's degree preferred. * 7 years of experience in HR, with 3+ years leading culture and engagement initiatives. * Demonstrated success in designing, developing and executing culture change and engagement improvement initiatives. * Experience in small and large global organizations, MedTech industry experience a plus. * Effective cross-cultural communication skills with appreciation for diverse perspectives. * An evidence-based, analytical approach to decision making. * Strong project and program management capabilities; ability to manage complex and ambiguous initiatives to great outcomes applying clear objectives, and metrics. * Ability to effectively guide and influence change with business leaders and key stakeholders, while also being hands on with tactical execution. * Strong verbal and written communications skills. Can translate ideas and data into a presentation to engage key stakeholders. * Ability to synthesize high-level information into action plans. * Proficiency with MS Office Suite tools such as Excel and PowerPoint in order to collect, visualize, and present data demonstrating business impact. * Workday experience a plus Additional details: This role is hybrid between Princeton, NJ and remote. Office days are Tuesday, Wednesday and Thursday Salary Pay Range: $109,250.00 - $149,500.00 USD Salary Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following ******************************************* Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at ***********************. Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails. Integra - Employer Branding from Integra LifeSciences on Vimeo
    $109.3k-149.5k yearly Auto-Apply 60d+ ago

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