Quality Engineer jobs at West Pharmaceutical Services - 315 jobs

We have an open position for a Packaging Development Associate Principal Engineer (Design controls / Combination products) based in our Pharmaceutical Technology and Development (PT&D) department. This role will support the entire PT&D portfolio. PT&D is the bridge, which turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations, and devices required to support new medicines - from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture. Make a positive impact, in a team where it means more. In Operations, we have a big ambition. to deliver more medicines to patients, quicker and more affordable. Backed by investment, leadership, and a clear plan to get there, we bring personal dedication and out-of-the-box thinking. What you will do: We will rely on you to bring a strong packaging perspective to the department, delivering our packaging strategy in a diverse, multi-skilled area, and supporting our packaging activities on development projects from Phase 1 to the transfer to Commercial Manufacture. You will work with Development and Operations colleagues across the company. * Lead the design & development, and testing of all packaging presentations for medical devices and combination products to achieve project targets in a timely fashion. * Accountable for developing innovative, creative, and cost-competitive packaging solutions that meet the needs and requirements of our patients, our sustainability objectives, and our quality standards. * Generate and review regulatory submission documents, plans, protocols, and reports ensuring that the project objectives are met (Design History File documentation). * Contribute and support relevant information to the Design transfer team to enable successful packaging transfer to AZ manufacturing operations and/or contract manufacturing sites. * Ensure that work is performed in accordance with appropriate safety (SHE), quality, and compliance standards. * Influence understanding and interpretation of packaging regulations. * Represent specialist packaging area (SME) on Device Project Teams, ensuring the provision of appropriate data (technical, resource & budgetary). * Understand and Influence developments within the industry. * Contribute to the training and development of packaging colleagues by acting as coach/mentor as appropriate. Minimum Qualifications: * BSc/PhD level education in a relevant Engineering field (Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Materials Engineering, Chemical Engineering), or in Pharmaceutical Sciences with related experience in the device and biopharmaceutical industry. * Minimum 7 years experience * Knowledge and application of cGMP requirements, Device and Combination Product requirements, in major pharmaceutical markets (USA, Europe) * Strong technical and scientific skills with proven experience in the development of packaging solutions for parenteral and/or Inhalation products. * Strong experience with medical device or combination product commercialization, operations support, and significant packaging materials/components knowledge * Lean Six Sigma Green Belt or higher certification with strong problem-solving skills * Demonstrated ability to simultaneously handle multiple projects of variable complexity. * Strong operational relationships with customers * Experience of leading cross-disciplinary delivery teams When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. Why AstraZeneca: Be part of shaping the future of Operations here at AstraZeneca. Be part of shaping the next phase of Operations' journey towards the 2025 strategy. Build on our foundations of high performance through agility, responsiveness, reliability, and efficiency to deliver our new modalities and complex pipeline to market at speed. Backed by a supportive team, be part of accelerating our operational excellence with innovations in cutting-edge science, Lean ways of working, and fast-changing digital technologies. Call to Action: Ready to make a difference? Apply today! LinkedIn ************************************** Facebook ******************************************** Minimum Date Posted 12-Jan-2026 Closing Date 29-Jan-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Manager, Biologics External Manufacturing Quality provides quality oversight for Eisai's biologics products manufactured at external partners (CMOs), covering Drug Substance (DS) and Drug Product (DP) including aseptic fill finish. The role ensures compliance with global GMP requirements and Eisai standards across product lifecycle, from cell banking and upstream/downstream processing through aseptic filling, packaging and release. The manager acts as Eisai's Quality contact for assigned sites, driving batch disposition readiness, deviation/CAPA governance, complaint management and proactive risk management to safeguard patient safety. The position collaborates with supply chain, technical operations, and CMC Program Management to review and support approval of deviations, change controls, batch records, validation protocols, quality agreements, and regulatory documentation. The Manager assists with batch disposition and supports external audit activities. Essential Functions: Review and approve batch records for DS and DP manufacturing, ensuring compliance and data integrity. Assess and approve deviations, investigations, and CAPAs related to DS and DP operations (e.g., EM excursions, media fill failures, process deviations). Oversee change controls impacting DS and DP processes. Support batch disposition activities to ensure timely and complaint product release. Monitor and track manufacturing data for integrity and compliance. Ensure CMO compliance with quality systems (change control, deviations, investigations, OOS results, validation, retain sample management). Contribute to evaluation of product complaints and regulatory compliance of CMOs. Review technical protocols, reports, batch records, and regulatory documentation related to DS and DP manufacturing and validation activities. Support development and maintenance of processes and procedures governing quality systems and CMO interactions. Collaborate with internal and external stakeholders to drive compliance, continuous improvement and risk mitigation across external manufacturing operations. Requirements: Education: BS/BA in life sciences or engineering (required); advanced degree desirable. Experience: 5+ years of Quality experience in biologics DS and DP operations, including aseptic fill-finish. Knowledge of EU GMP Annex 1 & Annex 2, FDA aseptic guidance, and global sterility assurance principles. Experience with DS processes (cell culture, purification) and DP aseptic operations (media fills, EM trending, contamination control strategies) Understanding of Quality System Management (lot disposition, deviations, change management, complaints). Strong organizational and communication skills; ability to manage multiple priorities. Proficiency in Microsoft Office tools. Ability to travel up to 25% (domestic and international). Required onsite Tuesday-Thursday Eisai Salary Transparency Language: The annual base salary range for the Mgr., Biologics External Mfg. Quality (Hybrid) is from :$104,800-$137,600Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ********************************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. This position is responsible for being the quality liaison between Philadelphia Quality Assurance and the client. Specific clients will be assigned to each Quality Program Manager with whom they will support and develop a Quality relationship. The Quality Program Manager must be flexible and have well-developed organizational skills and the ability to interact with all levels within the organization. This is a full-time on-site salaried position, Monday - Friday 8:00am - 4:30pm Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: Work closely with Catalent Philadelphia site to obtain necessary quality information for clients to support their projects and requests Plan, schedule, manage, and host customer, corporate, and internal audits. Support regulatory inspections as required Track audit reporting, drive completion of Catalent response to audit findings, and closure of audit actions Attend project kick-off meetings to assist various departments with understanding the project from a Quality perspective Attend client preparation calls and visits to ensure that the client receives any appropriate documentation requested and get questions answered Act as the primary contact person for client-specific quality questions and be the quality liaison between client and Catalent staff; Act as the primary contact with clients if there are quality questions on documentation, process questions, issues, etc Be knowledgeable about customer-specific requirements. Ensure they are built into the process and communicated to relevant Catalent staff Review deviation and complaint reports and address trends. Prepare communications regarding the results where appropriate and requested Other duties as assigned The Candidate: Bachelor's degree is required, life sciences or scientific degree is preferred Five years of relevant experience working in a pharmaceutical industry or life science industry is required Must possess regulatory and/or client audit experience Must have the ability to present Quality/ Compliance information both internally at Catalent and externally to clients Knowledge of cGMP's is required Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture Positive working environment focusing on continually improving processes to remain innovative Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of PTO + 8 paid holidays Several Employee Resource Groups focusing on D&I Dynamic, fast-paced work environment Community engagement and green initiatives Generous 401K match Medical, dental and vision benefits Tuition Reimbursement - Let us help you finish your degree or start a new degree! WellHub- program to promote overall physical wellness Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . **Purpose and Scope:** The Specialist, Quality Engineer will provide input and oversight to ensure compliant operations are effectively established and maintained through implementation, execution, and assessment of quality systems, procedures, and records to support compliant GMP operations. The Specialist, Quality Engineer will be tasked with performing a wide variety of activities to ensure that Astellas Quality requirements are being fulfilled through adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. This position works closely with Manufacturing, Engineering, Facilities, Document/Data Management, Quality Assurance, Quality Control and other GxP supporting functions to ensure compliance. **Essential Job Responsibilities:** + Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure + compliance to SOPs and relevant Good Regulated Practice (GxP) requirements. + Perform operations ancillary documentation review/approval, including but not limited to logbooks, work request, etc. + Perform Quality oversight of calibration and maintenance programs within the CMMS + Provide Quality oversight of the facility EMS program. + Provide Quality oversight of Facility programs such as pest control and access control. + Provide Quality review and approval of Engineering drawings within the Engineering EDMS. + Author, review, and approve controlled documents for the Quality organization and other GMP functional areas including SOPs, protocols, and reports. + Quality oversight to ensure documentation generated meets internal policy, procedures and regulatory expectations. + Author, execute, review, or approve Quality Management System records, including but not limited to non-conformances and change controls. + May facilitate risk assessments with cross functional teams in support of projects, programs or Quality System Records. + Define, track, and report quality metrics relevant to job responsibilities. + Assist in the preparation and hosting of regulatory (e.g. FDA, EMA, DHHS, etc.) inspections as needed. + May perform other quality assurance activities and responsibilities as assigned. **Qualifications** **Required:** + A./B.S. degree in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study and 5-8+ years of experience or M.S. degree and 3-5+ years of experience in a QA function in a biologics manufacturing facility or equivalent experienced quality professionals with 10+ years relevant quality experience in a biologics manufacturing facility. + Strong understanding of FDA, EMA, and ICH regulations and guidelines, as well as industry best practices. + Successful history working in a fast-paced team environment, meeting deadlines, and prioritization of work from multiple projects. + Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others. + Excellent problem-solving skills and experience with root cause investigations and CAPA determination. + Critical Quality Thinking skills as well as strong decision-making skills. + Advanced computer skills. + Off-hour coverage and flexibility may be required. **Preferred:** + Experience working in a clinical and commercial manufacturing environment (Drug Substance and Drug Product) + Experience working in a sterile fill/finish facility. + Experience working with Computerized systems, e.g. Microsoft Office, CMMS, TrackWise, EDMS, and Building Management System (BMS) **Working Environment:** + This position is based at Astellas Sanford Technology Center in Sanford, NC and will require on-site work at a cGMP regulated manufacturing facility. + On occasion, this role may travel to other Astellas facilities (0-5%) **Salary Range** **:** $93,100 - $146,300 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits** **:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program \#LI-TD Category BioPharma QA Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Build your best future with the Johnson Controls team As a global leader in smart, healthy and sustainable buildings, our mission is to reimagine the performance of buildings to serve people, places and the planet. Join a winning team that enables you to build your best future! Our teams are uniquely positioned to support a multitude of industries across the globe. You will have the opportunity to develop yourself through meaningful work projects and learning opportunities. We strive to provide our employees with an experience, focused on supporting their physical, financial, and emotional wellbeing. Become a member of the Johnson Controls family and thrive in an empowering company culture where your voice and ideas will be heard - your next great opportunity is just a few clicks away! What we offer: Competitive salary and bonus! Paid vacation with additional paid holidays and sick time Comprehensive benefits package including 401K, medical, dental, and vision care - available day one On the job/cross training opportunities Encouraging and collaborative team environment Dedication to safety through our Zero Harm policy A Day in the Life at Johnson Controls: ************************** What you will do The Field Quality Engineer will influence business bottom line results by leading, facilitating, and reporting Customer and Field related quality activities for each of our platforms. This role will bring improved connection between the customer and our internal functional teams. In this role, your responsibilities will include oversight of all quality related aspects for each equipment platform, primarily including failure analysis and data gathering based on customer provided feedback, resulting in the development of a clearly defined project pipeline - which will include analysis of factors that are utilized to define each project. The role will coordinate information from Product Technical Support teams, Field Teams via warranty and other data, Customer Interactions and Field Technicians to define the specific elements to be fixed or changed to improve the overall customer experience. This position will report to the Quality Director and is will be primarily located in the Airside Center of Excellence in York, PA. This role will not provide sponsorship to work in the United States now, or in the future. How you will do it Provide Field Quality leadership across assigned product families with a focus on driving improved customer quality experience across their assigned equipment portfolio. Provide data and impact analysis of improvement opportunities to leadership for project formation and resourcing. This will include actively tracking metrics to quantify effectiveness and accountability for conversion of opportunities to tangible customer benefits. Interact with, execute site visits, gather information, and provide appropriate responses to direct customers of our equipment portfolio to remedy customer issues. This will include doing customer research and customer investigations to understand root cause and calculation of benefits for quality improvements. Partner with PTS and Field Technical team members to develop effective communication strategies that allow JCI to focus on critical improvement deliverable. Development of a clearly defined project pipeline with priorities in place to deliver maximum benefit to our customers and the SBU. Providing leadership with data and tools to quantify and champion impactful quality improvement projects will be key to driving a change in our quality culture. Develop a strong understanding of customer perception/experience as it relates to equipment performance, Critical To Quality (CTQ) elements. Provide field facing data analysis to facilitate supplier, reliability, and other quality improvements into the NPI process. What we look for Required: Bachelor's degree in engineering, management or related discipline, including 5+ years of experience in quality in a low volume, high mix manufacturing environment. Excellent interpersonal skills, with demonstrated success in professional customer and supplier interaction. Ability to travel up to 10% with some peaks at higher levels. Solid interpersonal skills with the ability to influence and motivate associates and to interact with various departments throughout the organization Team oriented proactive change agent with a hands-on, collaborative approach in implementing and maintaining operating disciplines while leveraging lean methodologies Project management and planning tools, including monitoring of project activities and project trackers via relevant IT tools. #LI-Onsite HIRING SALARY RANGE: $85,000-107,000 USD (Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, location and alignment with market data.) This role offers a competitive Bonus plan that will take into account individual, group, and corporate performance. This position includes a competitive benefits package. For details, please visit the About Us tab on the Johnson Controls Careers site at ***************************************** Johnson Controls International plc. is an equal employment opportunity and affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, genetic information, sexual orientation, gender identity, status as a qualified individual with a disability or any other characteristic protected by law. To view more information about your equal opportunity and non-discrimination rights as a candidate, visit EEO is the Law. If you are an individual with a disability and you require an accommodation during the application process, please visit here.

**_This is an onsite position requiring the team member to be onsite 5 days a week. This position offers relocation assistance._** At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts. **Job Summary** Responsible for providing expertise in Quality Assurance processes related to the manufacture of West products. Ensure compliance with regulatory requirements and West procedures. Proactively develop, lead, and drive the execution of the Quality Assurance strategy. Develop and implement quality assurance plans ensuring compliance with regulations, oversee interactions with regulatory agencies and build strong relationships with internal and external stakeholders. Champion advocacy for product, process, and system quality, and drive continuous improvement within the Quality Management System. The position is a key and active member of the Site Leadership Team in West, Williamsport and interacts with the team to ensure business objectives are aligned and that the company is performing to operational objectives. **Essential Duties and Responsibilities** + Reporting to the Sr. Director, Quality Assurance, the role will play a critical part in the company's business planning / strategy development. + As a member of the Site Leadership Team, deeply engages and effectively contributes to the achievement of site objectives by playing an active role in the strategic planning processes + The role will also have a dotted line reporting relationship to the Director, Operations, Williamsport to ensure development and alignment of the site business plan including support to the other senior managers in the execution of same + Maintain a positive working relationship with internal and external stakeholders by supporting validation in design and development, specification development, and execution of manufacturing programs in line with agreed standards. All the while ensuring that West's product quality and reliability meets or exceeds customers' expectations. + Directs and manages quality control, quality assurance, quality systems, metrology and/or regulatory affairs, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output possible. + Partner with organizational leaders and drive quality initiatives, systems, and methods to meet quality objectives. Meet company and departmental goals in the continuous improvement of all products, services, and processes, including the West QMS. Support QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, and audit findings. + Perform the necessary functions in support of the Williamsport Quality System + Designated ISO 13485 Management Representative + Designated back-up to QA Supervisor for HACCP Manager and SQF Practitioner. + In accordance with US and other regional/ country legislation, act as Head of Quality Control/ Head of Quality/ Official Correspondent on all government agency issued authorizations, communications and registrations. + Cultivate a positive working relationship with the West Customer base via supporting validation in design and development, agreeing specification, execution of manufacturing and programs in line with agreed standards. All the while ensuring that the West's product quality and reliability meets or exceeds customers' expectations + QA representative participating in customer face to face steering committees and business review which originate from site customer base. Chairing customer meetings with respect to Quality standards and expectations. + Champion a quality/ patient first organizational culture that promotes behaviors that lead to superior quality and business performance and enterprise excellence. + Participate in customer, regulatory, and internal audits of the plant; participate in supplier audits and participate as part of the Corporate Cross Site Audit Team. + Review and assist on the updating of customer specifications. Respond to customer/sales regarding the approval or recommended changes to these specifications and maintain a file of the responses and the specifications. + Oversees complaint handling, non-conformance management, internal and external audits, and CAPA system to ensure timely and compliant systems. Evaluates and provides for audits of external and internal quality systems and their functions, insuring follow through and corrective actions. + Establish, monitors, and provides weekly / monthly progress of the Quality KPIs and communicate it to the organization and senior management. + Responsible and accountable for quality departmental budget + Other duties as assigned **Education** + Bachelor's Degree in engineering, mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering or equivalent experience required + Master's degree preferred **Work Experience** + 10+ Years of job-related experience required in the Medical Device or Pharmaceutical Industry. + 8+ Years of supervisory experience required. + 5+ Years of experience working with injection molding processes preferred. + 5+ Years of experience in an FDA or ISO regulated industry required, preferably in medical device manufacturing. **Preferred Knowledge, Skills and Abilities** + **Regulatory Skills:** In-depth knowledge of medical device and pharmaceutical regulations and guidelines, including cGMP, ICH guidelines and other relevant regulatory requirements (e.g. HACCP). + **Leadership Skills:** Strong leadership and management skills with the ability to lead cross-functional teams, drive initiatives, and influence stakeholders at all levels of the organization. + **Communication Skills:** Excellent communication skills, both written and verbal, with the ability to effectively communicate requirements and strategies to diverse audiences. + **Analytical Skills:** Strong analytical and problem-solving skills, with the ability to analyze complex problems, identify root causes, and develop effective solutions. + **Adaptability:** Flexibility and adaptability to navigate changing regulatory landscapes and business priorities. + **Ethical Standards** : Adherence to ethical standards and integrity in dealing with regulatory agencies, colleagues, and stakeholders. + Self-motivated with a proactive attitude and the ability to work effectively + Project Management experience preferred **Additional Requirements** + Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making. + Excellent written and oral communication skills + Medical component and device manufacturing require strict adherence to standards. + Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams + Read and interpret data, information, and documents + Must maintain the ability to work well with others in a variety of situations + Must be able to multi-task, work under time constraints, problem solve, and prioritize + Ability to make independent and sound judgments + Demonstrates enthusiasm, takes accountability, and drives for results. + Superior organizational and leadership skills with ability to help team grow and thrive + Able to lead and front multiple third party Medical Device / Pharmaceutical audits. + Able to interact with global Medical Device / Pharmaceutical agencies in support of queries / product launches. + Have in-depth / working knowledge of: ISO 13485, US FDA 21 CFR Part 820, ISO14971 + Have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention. Must have a proven track record of developing and maintaining positive customer relationships. + Able to lead and manage the performance of a multi-functional team. + Able to organize and prioritise tasks, must be detail orientated and self-motivated. + Have excellent written and verbal communication skills. Must be able to work in a fast paced environment. + Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description + Able to always comply with the company's safety and quality policy \#LI-JJ1 **Travel Requirements** 10%: Up to 26 business days per year **Physical Requirements** Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

Full-time Description Join Safeguard Medical - Where Purpose Meets Innovation At Safeguard Medical, we're not just shaping the future of emergency medicine-we're saving lives. We combine deep expertise with world-class equipment to empower first responders to act confidently and effectively when every second counts. Our mission is clear: To equip and enable responders at every skill level to preserve life in any environment. Our vision is bold: To simplify emergency medicine so that all responders have the confidence and tools to intervene when it matters most. Our purpose is powerful: To bring together life-saving products and the knowledge of emergency medical skills that preserve life. From category-leading medical devices to hyper-realistic SIMBODIES simulations, and a presence in key markets around the world, we're building a global movement-one that gives first responders the tools they need to make a difference in the toughest conditions. If you're driven by impact, inspired by innovation, and ready to grow in a company that's changing lives-this is your moment. About the Role We're on the lookout for a passionate Quality Engineer II to join our team onsite full time in Huntersville, NC. This isn't just a job-it's a chance to be part of something bigger. At Safeguard Medical, every role plays a part in our mission to preserve life and deliver excellence across the globe. What You'll Be Doing in This Role As a Quality Engineer II, you'll be right at the heart of our mission to preserve life. The Quality Engineer, as part of a cross-functional team, with primary responsibility for quality management related to Operational support, ensures that applicable elements of the Quality System and external standards are being followed. As the voice of Quality, the Quality Engineer applies quality best-practices including team-based and statistical tools and techniques, strong root cause analysis skills, and promotes the value and use of such tools throughout the organization. This role will lead and execute projects of varying complexity and must be able to connect well with all levels of the organization from operators and inspectors to management. The role should require minimal oversight from management and possess strong root cause analysis skills. Your key objectives: · Executing Quality Engineering activities in relation to Operational support, including support of risk management creation, classification of quality characteristics, technical drawings and specifications, design verification and validation, and process validation activities. · Performing root cause analysis of identified issues and identifies appropriate corrective and preventive action. Supports NC and Complaints/CAPA/SCAR systems within QE Team. · Using appropriate statistical tools such as collecting and summarizing data, drawing conclusions with confidence, determining sample sizes, applying Statistical Process Controls (SPC), identifying relationships between variables, and statistical decision making. · Supporting activities related to clean room monitoring and environmental controls. · Working closely with Quality Control team to ensure adequate resources to support manufacturing · Ensuring compliance with all practices in accordance with the Quality Management System. · Providing technical support for process improvements, supplier changes or design changes including but not limited to creation or updates to risk management documentation, ensuring comprehensive documentation is available, adequate records are produced, and change management is implemented for such changes. · Working with quality control, manufacturing, and warehouse personnel to implement processes and process improvements including related documentation · Executing control measures and drives resolution when supplier quality issues are identified. · Supporting supplier management principles such as supplier selection, qualification, certification, and performance improvement. · Applying the concepts of producer and consumer risk and related terms, including operating characteristic curves, AQL, LTPD, AOQ, AOQL, etc. Interprets and selects variable, attribute, and zero-defect sampling plans. Supports incoming inspection processes. · Developing and validates test methods with oversight as needed. Identifies and applies metrology techniques such as calibration systems, traceability, measurement error, and control of standards and devices. Conducts measurement system error studies such as Gage R&R. · Understanding the implementation of appropriate internal, national, and international requirements and standards. Performs internal and external audits as necessary (virtual and in-person) including supplier audits · Defining, identifying, and applying product and process control methods such as developing control plans, identifying critical control points, and developing and validating work instructions. · Contributing to corporate technical programs (e.g., system improvement, remediation, harmonization) in areas such as those identified in this position description Requirements You won't just be filling a role-you'll be making a difference. Every decision, every action, every idea you bring to the table helps responders around the world save lives when it matters most. Is This You? We're looking for someone who's ready to jump in and make a difference. Could that be you? You thrive in a team and bring a positive, can-do attitude to everything you do You're passionate about helping others and want to be part of something that truly matters in emergency medicine Detail-driven and reliable under pressure. Self-directed, demonstrating ownership and accountability with an aptitude and willingness to learn. Team-oriented personality Demonstrates the ability to plan, execute, control, and deliver on project tasks and overall goals. Strong written and verbal communication skills. Excellent problem-solving skills Strong organizational skills Collaborative personality with the ability to lead and influence others effectively without authority while creating and maintaining a positive environment. Ability to develop and maintain relationships with medical professionals, sales force, and cross functional team members. Understanding of change management, conflict resolution and team dynamics. Excellent critical thinking skills, including experience implementing the DMAIC thought process and structured root cause analysis, while employing a risk-based thought process. Ability to identify project and design risks and create mitigation strategies. Ability to independently make sound decisions with available information, through a risk-based approach. Ability to analyze data using statistical methods. You possess the following: · Bachelor's degree in a STEM discipline or equivalent experience required. · 3-6 years' experience in the medical device or pharmaceutical field preferred. · Technical knowledge and understanding of the medical device industry. · Must have experience in risk identification, mitigation, and risk management · Experience with manufacturing processes and related documentation preferred · Experience with sterilization and packaging validation activities preferred. · Minitab experience preferred. · Experience in 3D modeling and drafting preferred. · Proven track record of executing multiple projects / initiatives simultaneously, exhibiting appropriate prioritization of tasks and completing them with a sense of urgency If you're nodding along, we'd love to hear from you. Why Safeguard Medical? This is more than a career move-it's a chance to join a fast-paced, purpose-led company where your work truly matters. You'll be surrounded by passionate people, cutting-edge products, and endless opportunities to grow. Be part of a mission-driven organization with global impact Work with life-saving technologies and innovative solutions Join a collaborative, supportive, and inclusive team Build your career in a company that invests in people and progress Our Culture: Powered by Our DNA At Safeguard Medical, our culture is built on values that drive us every day: Ownership - We take charge, own our impact, and push for success. Initiative - We act boldly and do what's right, fast. Curiosity - We ask “why?”, explore better ways, and embrace diverse views. Candor - We speak openly and respectfully to align and move forward. Humility - We lead selflessly, knowing success is shared. We believe in learning from each other, valuing every voice, and creating a space where everyone belongs-regardless of background, identity, or ability. What You'll Get in Return We believe great people deserve great rewards. Here's what we offer to support your wellbeing, growth, and success (benefits may vary by country): Comprehensive insurance packages - peace of mind for you and your loved ones with medical, dental, vision and life insurance Competitive pay & performance bonus - because your impact deserves recognition Retirement support - employer contribution to help secure your future Generous time off allowance - time to recharge and enjoy life outside of work Employee Assistance Program (EAP) - confidential support when you need it most Tuition reimbursement &referral programs - invest in your growth and help us grow too Ready to Make a Difference? Ready to join our team? We'd love to hear from you. Click here Safeguard Medical - Job Opportunities to learn about future opportunities. Safeguard Medical is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to a work environment that supports, inspires, and respects all individuals and in which personnel processes are merit-based and applied without discrimination based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Safeguard Medical believes that diversity and inclusion among our teammates is critical to our success as a global company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. The above statements are not an exhaustive list of all required responsibilities, duties and skills for this job classification.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Purpose and Scope: The Specialist, Quality Engineer will provide input and oversight to ensure compliant operations are effectively established and maintained through implementation, execution, and assessment of quality systems, procedures, and records to support compliant GMP operations. The Specialist, Quality Engineer will be tasked with performing a wide variety of activities to ensure that Astellas Quality requirements are being fulfilled through adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. This position works closely with Manufacturing, Engineering, Facilities, Document/Data Management, Quality Assurance, Quality Control and other GxP supporting functions to ensure compliance. Essential Job Responsibilities: * Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure * compliance to SOPs and relevant Good Regulated Practice (GxP) requirements. * Perform operations ancillary documentation review/approval, including but not limited to logbooks, work request, etc. * Perform Quality oversight of calibration and maintenance programs within the CMMS * Provide Quality oversight of the facility EMS program. * Provide Quality oversight of Facility programs such as pest control and access control. * Provide Quality review and approval of Engineering drawings within the Engineering EDMS. * Author, review, and approve controlled documents for the Quality organization and other GMP functional areas including SOPs, protocols, and reports. * Quality oversight to ensure documentation generated meets internal policy, procedures and regulatory expectations. * Author, execute, review, or approve Quality Management System records, including but not limited to non-conformances and change controls. * May facilitate risk assessments with cross functional teams in support of projects, programs or Quality System Records. * Define, track, and report quality metrics relevant to job responsibilities. * Assist in the preparation and hosting of regulatory (e.g. FDA, EMA, DHHS, etc.) inspections as needed. * May perform other quality assurance activities and responsibilities as assigned.

Job DescriptionDescription: Join Safeguard Medical - Where Purpose Meets Innovation At Safeguard Medical, we're not just shaping the future of emergency medicine-we're saving lives. We combine deep expertise with world-class equipment to empower first responders to act confidently and effectively when every second counts. Our mission is clear: To equip and enable responders at every skill level to preserve life in any environment. Our vision is bold: To simplify emergency medicine so that all responders have the confidence and tools to intervene when it matters most. Our purpose is powerful: To bring together life-saving products and the knowledge of emergency medical skills that preserve life. From category-leading medical devices to hyper-realistic SIMBODIES simulations, and a presence in key markets around the world, we're building a global movement-one that gives first responders the tools they need to make a difference in the toughest conditions. If you're driven by impact, inspired by innovation, and ready to grow in a company that's changing lives-this is your moment. About the Role We're on the lookout for a passionate Quality Engineer II to join our team onsite full time in Huntersville, NC. This isn't just a job-it's a chance to be part of something bigger. At Safeguard Medical, every role plays a part in our mission to preserve life and deliver excellence across the globe. What You'll Be Doing in This Role As a Quality Engineer II, you'll be right at the heart of our mission to preserve life. The Quality Engineer, as part of a cross-functional team, with primary responsibility for quality management related to Operational support, ensures that applicable elements of the Quality System and external standards are being followed. As the voice of Quality, the Quality Engineer applies quality best-practices including team-based and statistical tools and techniques, strong root cause analysis skills, and promotes the value and use of such tools throughout the organization. This role will lead and execute projects of varying complexity and must be able to connect well with all levels of the organization from operators and inspectors to management. The role should require minimal oversight from management and possess strong root cause analysis skills. Your key objectives: · Executing Quality Engineering activities in relation to Operational support, including support of risk management creation, classification of quality characteristics, technical drawings and specifications, design verification and validation, and process validation activities. · Performing root cause analysis of identified issues and identifies appropriate corrective and preventive action. Supports NC and Complaints/CAPA/SCAR systems within QE Team. · Using appropriate statistical tools such as collecting and summarizing data, drawing conclusions with confidence, determining sample sizes, applying Statistical Process Controls (SPC), identifying relationships between variables, and statistical decision making. · Supporting activities related to clean room monitoring and environmental controls. · Working closely with Quality Control team to ensure adequate resources to support manufacturing · Ensuring compliance with all practices in accordance with the Quality Management System. · Providing technical support for process improvements, supplier changes or design changes including but not limited to creation or updates to risk management documentation, ensuring comprehensive documentation is available, adequate records are produced, and change management is implemented for such changes. · Working with quality control, manufacturing, and warehouse personnel to implement processes and process improvements including related documentation · Executing control measures and drives resolution when supplier quality issues are identified. · Supporting supplier management principles such as supplier selection, qualification, certification, and performance improvement. · Applying the concepts of producer and consumer risk and related terms, including operating characteristic curves, AQL, LTPD, AOQ, AOQL, etc. Interprets and selects variable, attribute, and zero-defect sampling plans. Supports incoming inspection processes. · Developing and validates test methods with oversight as needed. Identifies and applies metrology techniques such as calibration systems, traceability, measurement error, and control of standards and devices. Conducts measurement system error studies such as Gage R&R. · Understanding the implementation of appropriate internal, national, and international requirements and standards. Performs internal and external audits as necessary (virtual and in-person) including supplier audits · Defining, identifying, and applying product and process control methods such as developing control plans, identifying critical control points, and developing and validating work instructions. · Contributing to corporate technical programs (e.g., system improvement, remediation, harmonization) in areas such as those identified in this position description Requirements: You won't just be filling a role-you'll be making a difference. Every decision, every action, every idea you bring to the table helps responders around the world save lives when it matters most. Is This You? We're looking for someone who's ready to jump in and make a difference. Could that be you? You thrive in a team and bring a positive, can-do attitude to everything you do You're passionate about helping others and want to be part of something that truly matters in emergency medicine Detail-driven and reliable under pressure. Self-directed, demonstrating ownership and accountability with an aptitude and willingness to learn. Team-oriented personality Demonstrates the ability to plan, execute, control, and deliver on project tasks and overall goals. Strong written and verbal communication skills. Excellent problem-solving skills Strong organizational skills Collaborative personality with the ability to lead and influence others effectively without authority while creating and maintaining a positive environment. Ability to develop and maintain relationships with medical professionals, sales force, and cross functional team members. Understanding of change management, conflict resolution and team dynamics. Excellent critical thinking skills, including experience implementing the DMAIC thought process and structured root cause analysis, while employing a risk-based thought process. Ability to identify project and design risks and create mitigation strategies. Ability to independently make sound decisions with available information, through a risk-based approach. Ability to analyze data using statistical methods. You possess the following: · Bachelor's degree in a STEM discipline or equivalent experience required. · 3-6 years' experience in the medical device or pharmaceutical field preferred. · Technical knowledge and understanding of the medical device industry. · Must have experience in risk identification, mitigation, and risk management · Experience with manufacturing processes and related documentation preferred · Experience with sterilization and packaging validation activities preferred. · Minitab experience preferred. · Experience in 3D modeling and drafting preferred. · Proven track record of executing multiple projects / initiatives simultaneously, exhibiting appropriate prioritization of tasks and completing them with a sense of urgency If you're nodding along, we'd love to hear from you. Why Safeguard Medical? This is more than a career move-it's a chance to join a fast-paced, purpose-led company where your work truly matters. You'll be surrounded by passionate people, cutting-edge products, and endless opportunities to grow. Be part of a mission-driven organization with global impact Work with life-saving technologies and innovative solutions Join a collaborative, supportive, and inclusive team Build your career in a company that invests in people and progress Our Culture: Powered by Our DNA At Safeguard Medical, our culture is built on values that drive us every day: Ownership - We take charge, own our impact, and push for success. Initiative - We act boldly and do what's right, fast. Curiosity - We ask “why?”, explore better ways, and embrace diverse views. Candor - We speak openly and respectfully to align and move forward. Humility - We lead selflessly, knowing success is shared. We believe in learning from each other, valuing every voice, and creating a space where everyone belongs-regardless of background, identity, or ability. What You'll Get in Return We believe great people deserve great rewards. Here's what we offer to support your wellbeing, growth, and success (benefits may vary by country): Comprehensive insurance packages - peace of mind for you and your loved ones with medical, dental, vision and life insurance Competitive pay & performance bonus - because your impact deserves recognition Retirement support - employer contribution to help secure your future Generous time off allowance - time to recharge and enjoy life outside of work Employee Assistance Program (EAP) - confidential support when you need it most Tuition reimbursement &referral programs - invest in your growth and help us grow too Ready to Make a Difference? Ready to join our team? We'd love to hear from you. Click here Safeguard Medical - Job Opportunities to learn about future opportunities. Safeguard Medical is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to a work environment that supports, inspires, and respects all individuals and in which personnel processes are merit-based and applied without discrimination based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Safeguard Medical believes that diversity and inclusion among our teammates is critical to our success as a global company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. The above statements are not an exhaustive list of all required responsibilities, duties and skills for this job classification.

Full-time Description MORryde is seeking an experienced Quality Engineer to join our team. In this position, you will be tasked with assessing areas for improvement, devising a plan, and executing it to improve the quality standards within MORryde's manufacturing processes. Success will come from taking initiative, being passionate in your stance, and rallying a team to ensure implemented practices stand the test of time. In addition to bigger picture quality improvements, you will also be responsible for creating quality documents that will be utilized within our Quality Management System. Other responsibilities include inspection of new products, with review of internal incidents and customer nonconformances. Root cause analysis will be an important part of this position, as well as creating corrective action solutions. You will be responsible for monitoring quality performance, as well as communicating information regarding quality initiatives to relevant departments and customers. Requirements Basic use of measurement equipment Ability to interpret and read manufacturing prints Strong verbal and written communication skills Strong technical report writing abilities Outstanding interpersonal skills Experience with 8D problem solving process Customer focused attitude with the ability to work with a sense of urgency Basic skills in Microsoft Office (Excel, Word, Outlook) Ability to work with a diverse staff Ability to work within and lead a team Proactive approach to quality issues Continuous Improvement methodology ASQ Certification is preferred, but not required Teamwork is essential in this position, as you will work closely with Plant Managers, Engineering, Shop Floor Operations, and those in the Quality Department. Strong mathematical and communication skills are a must. The ideal candidate must be able to actively listen to various team members and customers and effectively communicate information to ensure quality standards are being met. Complex problem solving, critical thinking skills, and the ability to create technical quality documents are also important requirements. This is an opportunity that will allow you to excel, while utilizing a wide range of skills. MORryde is more than a place to work; it is an environment that will allow you to grow your capabilities by focusing on your strengths. MORryde provides an amazing company culture where the room for growth is endless. If you are passionate about quality practices, process improvement, mentoring, and coaching, then MORryde's Quality Team is the place for you.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Purpose and Scope: The Specialist, Quality Engineer will provide input and oversight to ensure compliant operations are effectively established and maintained through implementation, execution, and assessment of quality systems, procedures, and records to support compliant GMP operations. The Specialist, Quality Engineer will be tasked with performing a wide variety of activities to ensure that Astellas Quality requirements are being fulfilled through adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. This position works closely with Manufacturing, Engineering, Facilities, Document/Data Management, Quality Assurance, Quality Control and other GxP supporting functions to ensure compliance. Essential Job Responsibilities: Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance to SOPs and relevant Good Regulated Practice (GxP) requirements. Perform operations ancillary documentation review/approval, including but not limited to logbooks, work request, etc. Perform Quality oversight of calibration and maintenance programs within the CMMS Provide Quality oversight of the facility EMS program. Provide Quality oversight of Facility programs such as pest control and access control. Provide Quality review and approval of Engineering drawings within the Engineering EDMS. Author, review, and approve controlled documents for the Quality organization and other GMP functional areas including SOPs, protocols, and reports. Quality oversight to ensure documentation generated meets internal policy, procedures and regulatory expectations. Author, execute, review, or approve Quality Management System records, including but not limited to non-conformances and change controls. May facilitate risk assessments with cross functional teams in support of projects, programs or Quality System Records. Define, track, and report quality metrics relevant to job responsibilities. Assist in the preparation and hosting of regulatory (e.g. FDA, EMA, DHHS, etc.) inspections as needed. May perform other quality assurance activities and responsibilities as assigned.

SummaryThis position supports product leadership and risk management of new product development and sustaining activities for combination products. The role may include aspects of manufacturability, scalability, manufacturing transfer and post launch sustainability of combination products. We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Job Summary: This position supports product leadership and risk management of new product development and sustaining activities for combination products. The role may include aspects of manufacturability, scalability, manufacturing transfer and post launch sustainability of combination products. This is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future. Job Responsibilities: Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance) and chemical and pharmaceutical operations (e.g., drug product manufacturing, analytical testing, process development and quality assurance) Ability to create, support, review, and investigate analytical test methods used to support pharmaceutical combination devices. The ability to create, support, review chemistry, manufacturing, and controls device submissions Participates as team leader or as an active member of the team to meet company objectives and ensure department responsibilities are completed Leads development of risk assessments and test method activities (e.g., development and validation for physical and analytical test methods) Leads component qualifications, design validation, design verification, drug stability and process validation Leads product investigations Ability to make and present risked based decisions Assess product changes against product design Supports translation of design inputs into manufacturing control plans Develop and implement procedures to comply with corporate and industry standards. Coordinates and/or directs all aspects of product development activity related to a product line Leads development of risk assessments and test methods Quality engineering representation on Product Development and Design Review teams Prepare and present project updates and technical discussions Participate in project planning, budgeting, scheduling, and tracking Support internal and external supplier audits Provide support to the regulatory department in writing technical submissions Complies with company procedures and policies, government regulations Actively participates in training and providing input to training of employees on division procedures and policies Ability to travel for business, project, and issues approximately up to 25% of time. Other duties and projects, as assigned Education and Experience: BS in Engineering, biological science, or a related engineering field (Masters or Ph.D preferred). Fields of study include Chemical Engineering, Bioengineering, Pharmacy, or Biochemistry Minimum of eight years of experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry Pharmaceutical or combination product experience preferred Required Qualifications: Knows how products are used and impact the user(s) so that risk can be managed effectively Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.) Ability to lead creation of risk management files Ability to develop solutions with business impact Advanced statistical and risk assessment techniques Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies Ability to make and present risk-based decisions Strong interpersonal skills Ability to analyze and optimize manufacturing and quality systems Product, design & prototyping Ability to create and provide training Problem solving ability Ability to create, review and coordinate test protocols and reports Ability to generate engineering proposals Oral and written presentation skills Ability to lead cross functional teams Understanding of regulatory requirements including ISO 13485, ISO 14971, 21 CFR 210/211/820 , ICH Guidelines Preferred Qualifications: Quality Engineering Certification (ASQ) or equivalent Physical Demands: While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. Work Environment: While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. Travel required: ≤25% At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA AZ - Tempe HeadquartersAdditional LocationsWork Shift

Quality EngineerHubot Tri-Pac, Inc. South Bend, Indiana, United States (On-site) Hubot Tri-Pac, Inc. a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking for a Quality Engineer. Job Description This Quality Engineer oversees the manufacturing and engineering processes by ensuring the proper use of tools, materials, and procedures to monitor, test and report on the quality of the products. The Quality Engineer is responsible for the generation of a strategic plan to improve the business processes by ensuring compliance of the products and increase production output. The Quality Engineer must be self-directed and must show initiative in identifying and resolving opportunities for improvement, promoting Quality initiatives, and driving continual improvement in the Quality System. The Quality Engineer will pay close attention to detail, must possess analytical/critical thinking/problem-solving skills, possess excellent communication, ethics, math, and interpersonal skills. Responsibilities Supports efforts in conjunction with manufacturing and engineering to develop plans for continual improvement of product and process quality. Ensures that decisions are made based on sound Quality principles and regulatory guidelines. Supports/leads failure investigations, using root cause analysis tools, and proposing/implementing systemic corrective actions. Identifies areas of systemic weakness and leads initiatives to implement corrective action. Promotes use of statistical analysis for determination of improvements, and provides analyses to support risk mitigation. Implement and monitor all procedures and processes as they relate to Quarantine, Hold, Expired, Damages, Return Goods and Recalled product. Evaluate proposed changes for design control requirements. Guides engineering/ manufacturing personnel of appropriate qualification, validation criteria. Provides routine analysis of performance indicators and identifies trends. Presents this information to management, supervisors and manufacturing operators. Supports/leads initiatives to improve performance. Supports/leads teams to update risk management files for process changes. Focus team on implementing capable processes, process controls, and error-proofing measures. Collaborates with functional process owners to train, mentor and/or facilitate QMS requirements and continuous improvement. Monitoring the in-process quality check on the line. Reviews new Batch records and SOPs. Other duties as assigned. Education And/or Experience BA or BS Degree in Engineering, Quality Control or related field. 5 years relevant experience in Quality Engineering/manufacturing/ production processes Familiarity with industrial automation (e.g., distributed control and PLC-based systems) Working knowledge of safety, quality systems, and GMPs is required. Benefits Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/ Short term) and Continuous Training. Work where you are HAPPY! Tri-Pac, Inc. also recognizes the importance of continuing education and offers Education Assistance to our employees to encourage continued personal development and growth. ************** Thank you for your interest and consideration of a career with Hubot Tri-Pac, Inc. Hubot Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer Powered by JazzHR DdX7ZcSWyo

Join LifeLink - Join a Life Saving Team! About LifeLink More than four decades ago, a visionary group of innovators, led by renowned nephrologist Dr. Dana Shires, made a life-changing commitment-to save lives through organ and tissue donation. From that bold beginning, LifeLink Foundation was established - founded with heart, purpose, and a mission that still guides us today. What started as a nonprofit with big dreams has grown into a vision-driven organization of more than 700 dedicated professionals across west-central Florida, Georgia, parts of South Carolina, Puerto Rico, and the US Virgin Islands. At LifeLink, we are united by our mission: To honor donors and save lives through organ and tissue donation. Our vision remains clear: To maximize the gift of life while giving hope to donor families and transplant patients. We are grounded in the values that shape our work and culture-Compassion. Excellence. Legacy. People. Quality. If you're inspired by purpose, driven by impact, and ready to help save and heal lives, LifeLink is the place for you. What You'll Do As a Quality Review Coordinator 1, you will directly contribute to LifeLink's life-saving mission. The Quality Review Coordinator is responsible for assuring that standards for division specific activities related to organ recovery have been met thereby ensuring the safety and quality of organs recovered. Specific areas of responsibility include but are not limited to quality review of donor records, participating in audits to ensure compliance with regulatory standards, internal policies and procedures, assisting with training of OPO staff and assisting in the collection of data for reporting purposes. Key Responsibilities: Responsible for complete and accurate review of the donor and non-donor records according to policy, protocol, and guidelines. This includes all phases of the review. Supports Manager OPO Quality Systems in designated responsibilities including, but not limited to, OPTN reporting requirements, weekly and ad-hoc OPO data reports, OPO education of quality initiatives, policy review and updates, and audit preparation. Assure accurate and consistent data is submitted as required by regulatory/accreditation agencies (OPTN, CMS, etc.) for the designated OPO. Assists as directed with projects supporting organ activity and quality review. Performs audits of division specific activities as they relate to organ recovery and documentation to ensure compliance with all regulatory and accreditation standards as well as LifeLink policies and procedures. As a part of the Quality Team will handle and package donor serological specimens (blood/serum) for additional donor testing and/or archive in accordance with OPO protocols. Assists with organ discards, shipping of post case specimens and research organs as prescribed by OPO protocol. Coordinates with Recovery Services and quality personnel to ensure all required documentation is accurate and complete in accordance with LifeLink policies and procedures. Assists with inspections from regulatory and accreditation organizations including, but not limited to OPTN, CMS, and AHCA. Provides effective back-up to other quality personnel in accordance with established protocols and processes to ensure continuity within the quality team. Remains informed of developments in quality and regulatory issues as they relate to organ recovery through literature, attending seminars and/or conferences and disseminating such information to OPO personnel. Participates in departmental meetings and prepares data for review as requested by Manager. Participates in ongoing OPO QAPI initiatives as directed by Manager. Maintains full understanding of all related LifeLink Policies and Procedures. Responsible for participating in quality assessment performance improvement (QAPI) activities for the OPO as outlined in the OPO Quality Assessment Performance Improvement Plan.” Who You Are Passionate about helping others and making a difference Aligned with LifeLink's core values of Compassion, Excellence, Legacy, People, and Quality Bachelor's degree preferred, degree in Allied Science (RN, LPN, ORT, EMT, CST) and/or at least 3 years of experience in a healthcare related background preferred. Experience with Quality Assurance processes. Ability to analyze documentation and identify breaches in policy. Strong communication and writing skills. Mental ability and visual acuity to prepare and audit records and identify breaches in policy. Knowledge of the regulatory and quality standards established by OPTN, and CMS desirable. Knowledge of all organ recovery procedures including sterile technique, donor evaluation, donor management, organ placement, procurement, organ packaging/labeling, transportation and all appropriate documentation desirable. Must be able to lift up to 25 pounds. A collaborator who thrives in a mission-first environment Working Conditions: Position may require extended hours during peak recovery periods. Hazardous conditions include, but are not limited to, the possible exposure to microorganisms, viruses, potentially infectious body fluids and hazardous chemicals. OSHA Risk Classification: High Why LifeLink? Be part of an organization with a legacy of saving lives and giving hope Join a passionate and supportive team across Florida, Georgia, and Puerto Rico COMPANY PAID Medical, Dental, Disability & Life Insurance Generous COMPANY PAID Pension Plan for your Retirement Paid Vacation, Sick Days & Holidays Growth opportunities in a mission-driven, high-impact nonprofit Work with purpose, knowing your efforts directly touch lives Diversity, Equity & Inclusion LifeLink is proud to be an equal opportunity employer. We celebrate diversity and are committed to building an inclusive environment that reflects the communities we serve. Ready to Help Change Lives? Your next career move could be the most meaningful one yet.

Pharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for over 30 years. Since our inception, our services have resulted in project experience level and personnel resource base ranking among the highest worldwide. Currently, one of our clients in the North Region is looking to hire a Validation Engineer - Process Development. Requirements: * BS Engineering with at least 3 years of medical devices or pharma experience. * Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products. * Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities. * Work with the Process Development team to efficiently qualify new processes; assist on statistical sampling plans, and other development procedures. * Design and develop in-process and receiving quality systems for new processes and components. * Generate equipment documentation, such as equipment entries, evaluations, PM and calibration procedures, as required. * Define gages, tools and equipment for the test methods developed. * Generate manufacturing instructions for new processes being developed. * Work cross-functionally with other departments to accomplish PD tasks.

Essential Functions Monitor and maintain the state of inventory, quality, equipment, maintenance, calibration and facilities and ensure they comply with QS and cGMP requirements. Drive quality and compliance, adhering to all Quality Systems documentation requirements and establishing/supporting plans to exceed Niowave's goals for Quality, including Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD), and financial objectives. Support internal and external audits. Support validation of test methods, monitoring processes, and equipment. Support production teams in product/material hold, release, disposition, and traceability assessments, and implement improvements to reduce recurring deviations that lead to rework or scrap. Support new product introduction (NPI) quality activities including prototype testing, process validation, and technology transfer ensure successful product launches. Collaborate with cross-functional teams to support and solve production and quality challenges. Collect, monitor, analyze and communicate data to provide insight on quality metrics set by the management team.

Summary/objective The Quality Technician II plays a pivotal role in ensuring the effective, efficient, compliant, and proactive support of new product launches and the continuous quality of existing products. The Quality Technician loves details and precision. This role finds standardized work in which deviation could cause an undesirable outcome to be invigorating. Analyzing processes and results to control variations and discussing when improvements would best be introduced is a desirable pastime. Words that describe the Quality Tech are dedicated, efficient, and someone who contributes to making the workday fly by with engaging conversation and team comradery.

Job DescriptionRole Purpose: Validation Engineer:Support site commissioning and qualification, which includes but is not limited to the following: equipment, utilities, cleaning, process, assay qualifications. Ensuring the timely development, execution, and coordination of all validation activities pertaining to facility, equipment, and process in compliance with Quality System requirements, site procedures and regulatory requirements. This role will develop validation and Quality System documentation (e.g., IQ/OQ/PQ/SOP/Change Controls/Deviations/CAPAs etc.). This role will organize all validation activities ensuring project completion per schedule requirements. Key Duties & Responsibilities: Validation Engineer: Maintain the Company's compliance with established PLS Standard Operating Procedures and specifications and Current Good Manufacturing Practices. Write, execute and coordinate commissioning, qualification and validation protocol testing. Compile relevant commissioning/qualification/validation study data and generate summary reports to document the results of the studies. Aid in troubleshooting/impact assessment for atypical conditions during studies/ validations. Assist in the maintenance and development of any existing validation programs to ensure continued compliance with regulatory requirements. Provide scientific rationale/strategy for studies of new or modified GMP equipment and processes. Ensure all aspects of validation and qualification adhere to site and corporate policies and procedures, including safety and training. Review all errors, protocol deviations, and comments with the respective user department Management and QA and resolve discrepancies. Manage responsibilities and workload to assure accurate and timely data and reports. Initiate Change Controls in order to support validations in accordance with QMS processes. Perform investigations as needed to support QMS Deviation/CAPA processes. Implement Corrective/Preventive Actions related QMS CAPA processes which may require validation activities. Review completed validation, PM, and calibration documentation for accuracy and GMP compliance. Comply with FDA guidelines, Site and Corporate Policies for Data Integrity. Technical Supervisory Responsibilities: Validation Engineer: Ability to manage and plan multiple projects. Knowledge of cGMP's, GDP's and regulatory requirements as they related to qualification and validation activities (IQ/OQ/PQ). Possess a working knowledge of Microsoft Word, Windows, Excel, Power Point, and Statistical tools such as Minitab/Jmp. Must possess excellent analytical skills, good problem-solving technique and data analysis skills using Excel. Employee must have excellent communication skills, both written and verbal Employee must be collaborative when working with groups. Attention to detail is required. Onsite Personnel is an equal opportunity employer committed to hiring a diverse workforce in an inclusive culture environment. Onsite Personnel does not discriminate based on disability, veteran status or any other basis protected under federal, state, or local laws.

Are You Ready? CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide. For mission-critical and regulated industries needing to deliver essential solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard-through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our Purpose We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. Our Foundational Principles * At CAI, we are committed to living our values-both professionally and personally: * We act with integrity * We serve each other * We serve society * We work for our future * We are relentless in our dedication to excellence, pushing boundaries and redefining industry standards. We thrive at the intersection of wisdom, technology, and humanity-always focused on how it will be done, not how it used to be done. Key Responsibilities 1. Technical Responsibilities * Develop documentation for CQV activities * Write and execute protocols (field verification) * Develop summary reports at client sites 2. Areas of Focus * Pharmaceutical facilities * Utilities * Equipment 3. Project & Team Management * Plan and coordinate work * Direct small teams in document development and/or execution Qualifications and Experience * Bachelor's degree in a science or engineering field (or equivalent experience) * 2-4 years' experience in commissioning and qualification in a regulated industry * Familiarity with ISPE Baseline Guide 5 (Second Edition) is a plus * Preferred experience in: * Facilities and equipment startup * Walk-downs and troubleshooting * Utilities (WFI, RO, HVAC) * Upstream/downstream processing * Purification, recovery * Building automation * Pharmaceutical manufacturing processes Critical Competencies Influence Strategy * Pursues initiatives aligned with organizational strategy * Identifies strategic, innovative solutions * Anticipates emerging customer/market needs Satisfy the Customer * Understands and anticipates customer needs * Delivers high-quality solutions and service * Proactively maintains satisfaction and loyalty Plan for Success * Aligns business strategies with actionable plans * Anticipates risks and builds contingency plans * Secures resources for goal achievement Pursue Execution * Prioritizes time and resources effectively * Holds self and others accountable * Acts to overcome obstacles and improve quality Tailor Communication * Communicates clearly and professionally * Adjusts style to fit the audience * Explains technical concepts effectively Build Partnerships * Builds networks across functions * Encourages collaboration and breaks down silos * Involves stakeholders in decisions Influence Others * Builds support with sound rationale * Gains buy-in from decision makers * Encourages innovative thinking Develop Self and Others * Enhances interpersonal relationships * Models integrity and company values * Seeks out growth and breakthrough opportunities #LI-MV1 $72,800 - $80,100 a year Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment. CAI Benefits: * Comprehensive Health Insurance coverage * 24 days of Paid Time Off * ESOP/401K - 15% Company Contribution (US Only) * Company paid Life Insurance * Company paid Long Term Disability We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO). We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.