Quality Engineer jobs at Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION: MAIN PURPOSE OF THE ROLE Provide Process/Quality Engineering and Quality Systems support to distribution activities, helping to ensure delivery of highest quality product to the customer. MAIN RESPONSIBILITIES Support QMS Implementation and maintenance of applicable distribution sites. Activities include documentation updates, new releases of documents, QMS reviews for audit preparation, participation in internal and external agency audits Reduces and controls distribution process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. Execute qualification/validation activities to support distribution projects and internal process implementation driven by the business units. Own and execute improvement activities (CAPA/NCMR), performing root cause analysis, implementation of solutions to mitigate risk. Analyze complex interdisciplinary problems and identifies their impact, establishes probabilities, draws conclusions reflecting broad business needs, understands organizational and financial impact of recommendations, (e.g.,applies regulatory requirements and recommends best course of action). Responsible for product stops ship execution (containment, releases, disposition executions (scrap, rework, sort). Develops and implements quality plans, documents and systems by creatingquality specifications, risk analyses, FMEAs in conjunction with other cross functional teams Responsible for risk analyses and FMEAs of distribution processes. Develops and implements Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of distribution defects and devising methods to reduce process variation in order to reduce/eliminate the cause of defects. Collects and analyzes process defect data (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development. Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams. Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel. May lead a project team. Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions. Interact with business units/mfg site to support product flow or dispositions through distribution Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule. Establishes priorities of work assignments. (Decision Making/Impact) Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources. QUALIFICATIONS Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of various technical alternatives and their impact. Minimum 5 years preferred Wide application of technical principles, practices, and procedures. Strong understanding of business unit function and cross group dependencies/relationships. Strong verbal communications to work with highly matrixed organization. Quality System experience related to implementation and/or maintenance of quality management systems for effectiveness. Education Education Level Major/Field of Study or Equivalent Associates Degree (± 13 years) Experience/Background Experience Experience Details Minimum 4 years The base pay for this position is $75,300.00 - $150,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY:Operations QualityDIVISION:EP ElectrophysiologyLOCATION:United States > Avon : 10207 Veterans DriveADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:NoMEDICAL SURVEILLANCE:NoSIGNIFICANT WORK ACTIVITIES:Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Work in a clean room environment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************

**Join a team where innovation meets impact!** Stryker - Inari Medical is hiring a **Manager, Quality Engineering** in **Irvine, California** ! In this role, you'll lead and mentor a high-performing team of Design Quality Engineers who are shaping the future of medical technology. You'll guide and support their efforts on high-impact new product development ( **NPD** ) projects, ensuring design requirements are met and manufacturing processes are optimized to deliver life-changing solutions to patients! This is an onsite position with the option to work remotely one day per week. **What You Will Do:** + **Drive talent strategy** by attracting, developing, and retaining top engineering talent while fostering a culture of growth and high performance. + **Lead high-complexity projects** from concept to execution, managing budgets, timelines, and staffing to meet business goals. + **Ensure technical excellence** by overseeing design control activities for new and existing products and processes, guiding teams through risk management (e.g., FMEA), and reviewing or delegating approval of regulatory documentation in compliance with FDA 21 CFR Part 820 and ISO 13485. + **Make independent decisions** on projects, programs, and portfolio-level challenges to drive successful outcomes and support business strategy. + **Mentor and develop team members** by translating department goals into clear performance objectives and providing actionable feedback. + **Influence cross-functional collaboration** by building strong relationships across technical teams and business units-including Regulatory Affairs, Quality, Marketing, Clinical, Operations, and Finance-to drive innovation and alignment. + **Partner with customers and key opinion leaders (KOLs)** to develop technical strategies that align with clinical and business needs. + **Contribute to financial strategy** by managing project-level budgets and supporting broader R&D financial planning. **What You Will Need** **Required Qualifications** + Bachelor's degree in engineering or applicable technical discipline. + 8+ years of experience in engineering or a related technical field. + Experience in the medical device industry. + 3+ years of direct people management experience. **Preferred Qualifications** + Experience across the entire product lifecycle. + Experience mentoring in one or more technical or functional disciplines. + Proven ability to deliver programs on time, within budget, and to quality standards. + General knowledge of the healthcare market and competitive landscape. + Experience executing talent and performance management strategies. + Demonstrated ability to communicate complex technical plans across teams and leadership levels. $132,900 - $217,500 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role. Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Work Flexibility: Onsite Join a team where innovation meets impact! Stryker - Inari Medical is hiring a Manager, Quality Engineering in Irvine, California! In this role, you'll lead and mentor a high-performing team of Design Quality Engineers who are shaping the future of medical technology. You'll guide and support their efforts on high-impact new product development (NPD) projects, ensuring design requirements are met and manufacturing processes are optimized to deliver life-changing solutions to patients! This is an onsite position with the option to work remotely one day per week. What You Will Do: Drive talent strategy by attracting, developing, and retaining top engineering talent while fostering a culture of growth and high performance. Lead high-complexity projects from concept to execution, managing budgets, timelines, and staffing to meet business goals. Ensure technical excellence by overseeing design control activities for new and existing products and processes, guiding teams through risk management (e.g., FMEA), and reviewing or delegating approval of regulatory documentation in compliance with FDA 21 CFR Part 820 and ISO 13485. Make independent decisions on projects, programs, and portfolio-level challenges to drive successful outcomes and support business strategy. Mentor and develop team members by translating department goals into clear performance objectives and providing actionable feedback. Influence cross-functional collaboration by building strong relationships across technical teams and business units-including Regulatory Affairs, Quality, Marketing, Clinical, Operations, and Finance-to drive innovation and alignment. Partner with customers and key opinion leaders (KOLs) to develop technical strategies that align with clinical and business needs. Contribute to financial strategy by managing project-level budgets and supporting broader R&D financial planning. What You Will Need Required Qualifications Bachelor's degree in engineering or applicable technical discipline. 8+ years of experience in engineering or a related technical field. Experience in the medical device industry. 3+ years of direct people management experience. Preferred Qualifications Experience across the entire product lifecycle. Experience mentoring in one or more technical or functional disciplines. Proven ability to deliver programs on time, within budget, and to quality standards. General knowledge of the healthcare market and competitive landscape. Experience executing talent and performance management strategies. Demonstrated ability to communicate complex technical plans across teams and leadership levels. $132,900 - $217,500 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors. Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

SummaryThe primary function of this position is to support the maintenance of site wide compliance and the Quality Systems; such as: hosting customer audits, performing internal audits, corrective action and preventative actions (CAPA), develop and deliver training and perform root cause investigations with the ability to offer sustainable actions. The Document Control focus area is responsible for the coordination and management of the BDM, PS Columbus document control system and the implementation of the SAP document structures. Is the subject matter expert for the Columbus BDM, PS document control system and has the local responsibility for the development, implementation, and improvements of the document system as well as maintaining it in compliance with ISO, cGMP, BDM, PS and BDX requirements. Interfaces directly with BDM, PS sites in Franklin Lakes, Pont de Claix, and Cuautitilan, and the BD Corporate Document group on document control matters. Ensures compliance with BD quality systems, policies, procedures and best practices, and all local, state, federal and BD safety regulations, policies and procedures. Regular, punctual attendance is an essential job function. Ability to read and write and converse in English. Willing and able to uphold BD Values.Job Description 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. JG3 1st shift - Monday-Friday 8:00AM-5:00PM Responsibilities include but are not limited to: Audit focus area: Provides assistance with hosting customer audits, maintaining minutes, generating reports for customers and tracking actions through completion. Effectively represent BD in customer facing role during audits. Conducts internal audits with lead auditor responsibilities. Maintain metrics for the quality systems and perform data review which may lead to CAPA. Perform root cause investigations for customer complaints including report generation and follow up on actions. Support site and Worldwide quality boards (audits, CAPA, and CIR) and Management Reviews in data capture/review and report generation and tracking of actions in a timely manner. Utilize Trackwise or other tracking systems and be able to perform user training of the system. Actively coordinate and follow up on actions to meet due dates. Document Control focus area: Brings a high level of manufacturing process and Quality Systems understanding to the review and approval process and has the authority to reject documentation packages when they do not comply with process or system requirements. Is responsible for assuring that document types and formats submitted for approval are compliant with BDM, PS and BDX requirements as well as compliance to required approval routings and has the authority to reject document packages when these requirements are not followed. Develops and delivers training for associates in use of documentation system and the Engineering Change Order process and mentors users in the document control process. Is responsible for the quality and accuracy of the site Electronic Document System (eDoc) including security for access to the system, creation/maintenance of menus, placement of documents (pdf format) on local server, and application of security to block print capability on designated documents. Provides Help Desk support to users of documentation system. This includes creation and monitoring of incident tickets requiring help desk support from System Administrator in Franklin Lakes, NJ. Provides timely review and approval of all site document revisions/creations and associated Engineering Change Orders (ECOs) Is the primary document control approval signature for all document and EDO routings. Assists change originators in coordination of document releases. Coordinates the site 3-year review program by providing a rolling one year schedule of documentation requiring review, and providing a report to the plant leadership team on departmental and overall compliance to the process. Maintains: Site document templates in documentation system User accounts in documentation system Site procedures related to document control and table of content Archive area specific to the document control group Document legacy systems Databases used for document system (i.e. TWI Log and Report Card, Document Distribution, Document Number Assignments, User Security Accounts, etc.) Leads conversions and upgrades to documentation systems for site. Is responsible for identifying and implementing efficiency improvements to the overall document control process. Other duties as required to support the needs of the business. Audit focus: Successfully host customer audits, Conduct and lead internal audits, Accurate metric documentation, Represent BD Columbus in WW Quality Systems Functions. Document Control focus: Accurate document system, maintenance of and integrity of eDocs system, Timely reporting of document review compliance. Supervision: This position does not supervise any associates at any level Minimum Education : Required : BA/BS Degree: Science, Business, Quality or Manufacturing related field Minimum Experience : 2-3 years of experience with BDM, PS product and production methods, including experience with Quality System's standards (QSR, GMP and ISO) Prior experience in the application of the plant Quality System and SAP preferred. Knowledge skills: Proficient : Attention to detail Understanding of the business and manufacturing process that are supported by documentation system Computer skills including knowledge of Windows, Word, Excel, Documentum, SAP and database programs Complete understanding of the CD/ECM change management (regulatory) procedures and policies Communication skills Analytical skills Problem solving skills Organizational skills Interpersonal skills Self motivated Ability to manage change Leadership skills 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. BD is committed to providing a robust set of value-based programs and resources that are best-in-class, market-competitive and affordable for all associates and their families. Competitive pay Access a portion of your pay before pay day with DailyPay Healthcare coverage: No paycheck contributions for eligible associates under a certain salary threshold enrolled in the HSA Basic Medical Plan option, no matter how many dependents you cover. Preventive care covered at 100%. Dental and vision insurance at group rates. Paid parental leave up to 6 weeks Adoption assistance plan 401(k) plan with 75 cents on the dollar matched by BD up to 6% of compensation Company paid basic life and AD&D insurance Tuition reimbursement Discounted home, auto and pet insurance Paid holidays and vacation (pro-rated the first year based on actual start date) All benefits and policies are subject to eligibility and enrollment requirements. Most coverage begins on your first day or the date you become eligible for benefits. 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 NE - Columbus (East) Additional LocationsWork Shift

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. **Quality Project Leader, Packaging Supplier Quality** **Working at Abbott** Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac , PediaSure , Pedialyte , Ensure , and Glucerna - to help them get the nutrients they need to live their healthiest lives. At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will also have access to: + **Training and career development** , with onboarding programs for new employees and tuition assistance. + **Financial security** through competitive compensation, incentives, and retirement plans. + **Health care and well-being programs** including medical, dental, vision, wellness and occupational health programs, **Medical Benefits start day 1.** + **Vacation - 3 weeks accrued vacation (1st yr. is prorated) + vacation buy program + 3 personal days + 10 paid holidays.** + **401(k)** retirement savings with a **generous company match of 5%.** + Tuition reimbursement, the Freedom 2 Save (******************************************************************************************************* student debt program and FreeU (*************************************************************************************************************** education benefit - an affordable and convenient path to getting a bachelor's degree. + A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. + A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. + **The stability of a company** with a record of strong financial performance and history of being actively involved in local communities. **The Opportunity** Our location in Columbus, OH, currently has an opportunity for a **Quality Project Leader, Packaging Supplier Quality** . **Primary Function:** The primary function of Supplier Quality Assurance (SQA) is to assure a high-quality supply of materials through evaluation and development of Abbott Nutrition suppliers worldwide. Packaging SQA is responsible for working and communicating with packaging suppliers as part of an ongoing supplier management process. Packaging SQA supports the following areas: (1) Supplier qualification, (2) Supplier development & monitoring, (3) Supplier corrective & preventative actions, (4) Continuous improvement of department & supplier performance, and (5) Regulatory documentation. Additionally, Packaging Supplier QA supports the plant quality assurance, operations, and purchasing groups to ensure (1) Proper incoming material, (2) Effective Corrective & Preventative Actions (CAPA), (3) Testing and release of products, and (4) Ensure acceptance plans and specifications are compliant to corporate and regulatory requirements. **WHAT YOU'LL DO** + Collaborate closely with key packaging suppliers to monitor, assess, and enhance their quality performance. + Assist with, initiate, investigate, and/or plan correction activities, as required, when nonconformances are identified and lead or support the resolution and closure. + Support and influence suppliers to drive to true root cause and implement effective corrective actions. + Evaluate supplier capabilities, identifying strengths and areas for improvement, and engage with supplier leadership to drive sustainable, long-term improvements. + Own and manage supplier scorecards and KPIs; conduct weekly reviews to analyze performance trends and lead initiatives for continuous improvement. + Lead investigations into quality issues using root cause analysis tools (e.g., 5-Why, Fishbone, statistical methods), ensuring effective corrective actions are identified, implemented, and validated. + Conduct or support supplier site assessments, audits, and qualification activities to ensure systems, processes, and facilities meet Abbott and regulatory requirements. + Manage supplier CAPAs and improvement plans, including exception report resolution and ongoing performance monitoring. + Support the development of supplier systems and processes to improve quality, process capability, and compliance. + Coordinate with Abbott manufacturing sites on supplier corrective actions, sampling plans, and validation of improvements. + Ensure appropriate sampling plans are in place for routine production and post-corrective action verification. + Maintain and evaluate the approved supplier list and ensure proposed process changes are reviewed and compliant. **Required Qualifications** + Bachelor of Science degree in engineering, technical, or science field required. **Preferred:** + Preferred experience within a Global, multi-cultural organization. + Minimum of 3 years of experience in quality, packaging engineering, supplier quality assurance programs or related experience in operations, or quality assurance. + Demonstrated ability to manage several activities / projects at once, organize / prioritize work. **MISC:** + This is an onsite role located in Columbus, OH - this is not a remote role/opportunity. + There is no relocation assistance for this role. Apply Now (****************************** **Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** ********************** (http://**********************/pages/candidate.aspx) Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at ************** , on Facebook at *********************** , and on Twitter @AbbottNews. The base pay for this position is $66,700.00 - $133,300.00. In specific locations, the pay range may vary from the range posted. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call ************ or email ******************

SummaryGENERAL FUNCTION: To assist the Manufacturing Departments in the establishment and implementation of programs designed to assure control of processes and products toward established standards of quality. To use problem solving techniques to increase quality and productivity within the business.Job Description 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 Position Title: Manufacturing Quality Engineer Function: Quality Location: Columbus West Job Group/Grade: JG3 Position Summary: Assist the Manufacturing Departments in the establishment and implementation of programs designed to assure control of processes and products toward established standards of quality. Use problem solving techniques to increase quality and productivity within the business. Ensures compliance with BD quality systems, policies, procedures and best practices, and all local, state, federal and BD safety regulations, policies and procedures. Regular, punctual attendance is an essential job function. Ability to write programs supporting the implementation of the eDHR project. Ability to read and write and converse in English. Willing and able to uphold BD Values. Duties/Responsibilities: Develop, change, and supervise in-process inspections to ensure the greatest value in process control for the customer and the plant during the manufacturing process while meeting regulatory requirements. Process monitoring and adjustment, process and product improvement, including corrective action plans to address complaint issues. Documentation of these activities along with the review and maintenance of S.O., O.I.s and department specific operating procedures such as manufacturing cleaning procedures. Employee training of Quality Control concerns regarding Process specifications. Develop and implement procedures applicable to the total plant manufacturing process. Coordinate efforts with Process Engineering, Production for the establishment of controls, which support current product designs, and process capabilities for assigned product lines. Assistance in such areas as process validation, process acceptance, certain audit correction actions, Change Control issuance for process changes. Support CAPAs as owner or as part of the support team. Moniitor the performance of assigned product lines about product quality levels, waste, and rejection rates. Leading / mentoring / conducting quality improvement projects thru CI initiatives. May acquire Green/Black Belt Certification. Develop the acceptance and validation of process / equipment. Review and develop changes in existing or proposed processes or requirements to achieve optimum performance and quality, cost. Assume a role of leadership in analyzing and resolving issues, which prevent desired quality levels achievement. Develop programs for the maintenance, replacement, and improvement of inspection gauging. Stay informed as to the latest requirements of federal regulations and corporate policies regarding medical devices. Lead and ensure regulatory compliance is met and that the manufacturing unit is trained on all requirements. Own and continue to improve department training systems. Monitor customer complaints and trends. Respond as needed for specific corrective action and customer interface. Provide support and guidance on quality/ process improvements. Ensure that all company safety rules and regulations are followed and promote general plant safety. Own and lead efforts to reduce and eliminate rejections. Assist in internal/ external audits and supplier certification processes as needed. Other duties as to support the needs of the business Education: Bachelor's degree Experience: Three years manufacturing experience with broad background in manufacturing process Two years Process Control experience Three years practical GMP/Medical Devise manufacturing experience Validations experience, preferred. Knowledge, Skills and Abilities: Effective Oral/written Communication - Proficient Ability to work as part of a team / Teambuilding - Advanced Independent thinking / Self Driven - Proficient Decision Making Ability - Proficient Computer Skills / Microsoft Office - Proficient eDHR related software. Product / process improvements utilizing Green/ Black Belt/Six Sigma techniques. Ability to generate validation protocols, which align with the globalization standardization initiative. PCP Level: N/A 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. BD is committed to providing a robust set of value-based programs and resources that are best-in-class, market-competitive and affordable for all associates and their families. Competitive pay Access a portion of your pay before pay day with DailyPay Healthcare coverage: No paycheck contributions for eligible associates under a certain salary threshold enrolled in the HSA Basic Medical Plan option, no matter how many dependents you cover. Preventive care covered at 100%. Dental and vision insurance at group rates. Paid parental leave up to 6 weeks Adoption assistance plan 401(k) plan with 75 cents on the dollar matched by BD up to 6% of compensation Company paid basic life and AD&D insurance Tuition reimbursement Discounted home, auto and pet insurance Paid holidays and vacation (pro-rated the first year based on actual start date) All benefits and policies are subject to eligibility and enrollment requirements. Most coverage begins on your first day or the date you become eligible for benefits. 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 NE - Columbus (West) Additional LocationsWork Shift

#LI-Remote Proximity to an RLT site, especially Indianapolis, preferred. This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 25% travel. Are you ready to lead quality operations that directly impact patient safety and product excellence? As the RLT Quality Operations Lead for the US, you'll shape the future of radioligand therapy manufacturing, championing best practices and driving innovation across multiple sites. Join a team where your expertise will empower high-performing colleagues and ensure our therapies reach those who need them most. About the Role Key Responsibilities: * Provide strategic leadership for quality operations across US radioligand therapy manufacturing sites. * Define and implement the operating model for US quality operations, including organization design and performance management. * Ensure compliance with current Good Manufacturing Practice (cGMP) standards and global Novartis quality policies. * Ensure robust product quality oversight for RLT products, including radiopharmaceutical-specific controls, aseptic and sterile manufacturing practices, and distribution considerations. Champion safety, ethical compliance, and patient-centric decision making in all quality activities. * Lead inspection readiness and successful execution of health authority, customer, and internal inspections. * Oversee site-level Quality functions (e.g., QA Operations, QC Laboratories, Batch Release, Deviation/Investigation Management, Change Control, Supplier Quality, Validation, Documentation Control). * Partner with Manufacturing, Supply Chain, MS&T, Regulatory Affairs, EHS, and Global Quality to enable reliable, compliant supply to US and international markets. * Drive harmonization of quality systems and digital tools across sites, promoting data integrity and lifecycle management. Essential Requirements * Bachelor's degree in a scientific discipline required; advanced degree preferred. * Minimum 10 years of progressive quality experience in pharmaceuticals or biologics, with at least 7 years in radiopharmaceuticals or sterile/aseptic operations. * Previous experience as a Site Quality Head. * Working knowledge of Food and Drug Administration (FDA), European Medicines Agency (EMA), and International Council for Harmonization (ICH) regulatory requirements. * Proven track record of successful regulatory inspections, corrective and preventive action (CAPA) management, and quality system deployment. * Strong people leadership skills, including team building, talent development, and stakeholder management. The salary for this position is expected to range between $168,000 and $312,000 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

#LI-Remote Proximity to an RLT site, especially Indianapolis, preferred. This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 25% travel. Are you ready to lead quality operations that directly impact patient safety and product excellence? As the RLT Quality Operations Lead for the US, you'll shape the future of radioligand therapy manufacturing, championing best practices and driving innovation across multiple sites. Join a team where your expertise will empower high-performing colleagues and ensure our therapies reach those who need them most. Job Description Key Responsibilities: Provide strategic leadership for quality operations across US radioligand therapy manufacturing sites. Define and implement the operating model for US quality operations, including organization design and performance management. Ensure compliance with current Good Manufacturing Practice (cGMP) standards and global Novartis quality policies. Ensure robust product quality oversight for RLT products, including radiopharmaceutical-specific controls, aseptic and sterile manufacturing practices, and distribution considerations. Champion safety, ethical compliance, and patient-centric decision making in all quality activities. Lead inspection readiness and successful execution of health authority, customer, and internal inspections. Oversee site-level Quality functions (e.g., QA Operations, QC Laboratories, Batch Release, Deviation/Investigation Management, Change Control, Supplier Quality, Validation, Documentation Control). Partner with Manufacturing, Supply Chain, MS&T, Regulatory Affairs, EHS, and Global Quality to enable reliable, compliant supply to US and international markets. Drive harmonization of quality systems and digital tools across sites, promoting data integrity and lifecycle management. Essential Requirements Bachelor's degree in a scientific discipline required; advanced degree preferred. Minimum 10 years of progressive quality experience in pharmaceuticals or biologics, with at least 7 years in radiopharmaceuticals or sterile/aseptic operations. Previous experience as a Site Quality Head. Working knowledge of Food and Drug Administration (FDA), European Medicines Agency (EMA), and International Council for Harmonization (ICH) regulatory requirements. Proven track record of successful regulatory inspections, corrective and preventive action (CAPA) management, and quality system deployment. Strong people leadership skills, including team building, talent development, and stakeholder management. The salary for this position is expected to range between $168,000 and $312,000 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $168,000.00 - $312,000.00 Skills Desired Agility, Agility, Business Acumen, Business Partnering, Business Strategy, Collaboration / Teamwork, Communication Skills, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Employee Performance Evaluations, Finance Acumen, Gmp Procedures, Goal-Oriented, Health Authorities, Leadership, Logical Thinking, People Management, Problem Solving Skill, Problem Solving Skills, Qa (Quality Assurance), Self-Awareness, Smart Risk Taking, Stakeholder Management, Storytelling {+ 4 more}

SummaryJob Description 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. Responsibilities: Establish a robust process window by applying Scientific / Decoupled Molding techniques along with design of experiments (DOEs). Establish a relationship between key process input variables (KPIVs) and key process output variables (KPOVs) for each component. Specify the equipment required in the molding cell for an application to include molding press, robot, EOAT, hot runner controller, water temperature controller, material loader, weigh blender, dryers, inspection equipment, etc. Participate in factory acceptance tests (FATs) at the mold vendor. Read and maintain a working knowledge of Quality Procedures and Work Instructions. Provides technical process support to the organization and mentor molding technicians. Interface with the Manufacturing Manager on a daily basis to determine production needs related to process and other technical issues in order to improve OEE and reduce scrap. Manage sampling program. Establish documentation requirements for all processes including but not limited to: Process sheets and database for set-up information, special notes and to maintain required history. Create and administer training programs for Process and Mold Setup Technicians as well as existing staff on new equipment. Maintain knowledge of production schedule and ensure technical issues are acknowledged and addressed to support schedule. Act as technical lead responsible for new mold sampling, DOE's, material samples, engineering changes, etc. Establish injection Molding and robotic process for all new jobs. Establish acceptable process variation allowances and associated process window. Act as technical lead on OEE improvement projects including scrap reduction through controlled planning and process\equipment improvements with Operations Manager. Assist in all automation projects and actively participate in continuous improvement activities. Provide technical guidance for mold and hot runner design. Coordinate and control all cost, delivery and quality objectives for the design, construction and validation of assigned injection molding projects. Establish a robust process window for all injection molded components using Scientific Molding techniques along with Design for Experiments (DOE's). Ensure molding cell is sized properly for the application. Other duties as required to support the needs of the business. Supervision: This position supervises does not supervise associates at any level Education: Required : HSD/GED Preferred : Associates degree - Plastics Engineering or related Engineering field Preferred : BA/BS - Plastics Engineering or related Engineering field Minimum Experience : 10 years medical molding experience with High School Diploma 5 years' experience with Associates Degree No experienced required with Bachelor's degree in related field 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. BD is committed to providing a robust set of value-based programs and resources that are best-in-class, market-competitive and affordable for all associates and their families. Competitive pay Access a portion of your pay before pay day with DailyPay Healthcare coverage: No paycheck contributions for eligible associates under a certain salary threshold enrolled in the HSA Basic Medical Plan option, no matter how many dependents you cover. Preventive care covered at 100%. Dental and vision insurance at group rates. Paid parental leave up to 6 weeks Adoption assistance plan 401(k) plan with 75 cents on the dollar matched by BD up to 6% of compensation Company paid basic life and AD&D insurance Tuition reimbursement Discounted home, auto and pet insurance Paid holidays and vacation (pro-rated the first year based on actual start date) All benefits and policies are subject to eligibility and enrollment requirements. Most coverage begins on your first day or the date you become eligible for benefits. 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 NE - Columbus (East) Additional LocationsWork Shift

#LI-Remote Proximity to an RLT site, especially Indianapolis, preferred. This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 25% travel. Are you ready to lead quality operations that directly impact patient safety and product excellence? As the RLT Quality Operations Lead for the US, you'll shape the future of radioligand therapy manufacturing, championing best practices and driving innovation across multiple sites. Join a team where your expertise will empower high-performing colleagues and ensure our therapies reach those who need them most. About the Role Key Responsibilities: * Provide strategic leadership for quality operations across US radioligand therapy manufacturing sites. * Define and implement the operating model for US quality operations, including organization design and performance management. * Ensure compliance with current Good Manufacturing Practice (cGMP) standards and global Novartis quality policies. * Ensure robust product quality oversight for RLT products, including radiopharmaceutical-specific controls, aseptic and sterile manufacturing practices, and distribution considerations. Champion safety, ethical compliance, and patient-centric decision making in all quality activities. * Lead inspection readiness and successful execution of health authority, customer, and internal inspections. * Oversee site-level Quality functions (e.g., QA Operations, QC Laboratories, Batch Release, Deviation/Investigation Management, Change Control, Supplier Quality, Validation, Documentation Control). * Partner with Manufacturing, Supply Chain, MS&T, Regulatory Affairs, EHS, and Global Quality to enable reliable, compliant supply to US and international markets. * Drive harmonization of quality systems and digital tools across sites, promoting data integrity and lifecycle management. Essential Requirements * Bachelor's degree in a scientific discipline required; advanced degree preferred. * Minimum 10 years of progressive quality experience in pharmaceuticals or biologics, with at least 7 years in radiopharmaceuticals or sterile/aseptic operations. * Previous experience as a Site Quality Head. * Working knowledge of Food and Drug Administration (FDA), European Medicines Agency (EMA), and International Council for Harmonization (ICH) regulatory requirements. * Proven track record of successful regulatory inspections, corrective and preventive action (CAPA) management, and quality system deployment. * Strong people leadership skills, including team building, talent development, and stakeholder management. The salary for this position is expected to range between $168,000 and $312,000 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

SummaryJob Description 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 Group/Grade: JG3 Position Summary: Responsible for process capability, cost reduction and continuous improvement project implementation within their designated manufacturing unit. Provides specific engineering work related to field of expertise with broad overlap between engineering disciplines expected. Support capacity planning and growth, as well as define budgeted rates and process documentation. Ensures compliance with BD quality systems, policies, procedures and best practices, and all local, state, federal and BD safety regulations, policies and procedures. Regular, punctual attendance is an essential job function. Ability to read and write and converse in English. Willing and able to uphold BD Values. Duties/Responsibilities: Implements and sustains BD Excellence work process for the manufacturing unit. Identifies critical equipment setting and creation of standards. Creates technical knowledge for the manufacturing unit and transfers the knowledge to the operator and technical associates. Coaches associates on continuous improvement methodologies within the manufacturing unit. Understands top losses within the manufacturing unit and develops and implements plans to eliminate losses and drive OEE performance. Responsible for manufacturing unit change control including validation activities, root cause analysis of prioritized OEE losses, and quality events and deviations. Other duties as required to support the needs of the business Education: Bachelor's Degree required in Engineering, Mechanical Engineering preferred. Experience: Two years Medical manufacturing experience preferred Three years manufacturing experience preferred Knowledge, Skills and Abilities: Effective Oral/written Communication - Proficient Ability to work as part of a team / Teambuilding - Proficient Independent thinking / Self Driven - Proficient Decision Making Ability - Proficient Machine Design - Proficient Troubleshooting / Problem Solving - Advanced Safety & Ergonomics Expertise - Proficient Project Management - Basic Quality Systems Knowledge - Proficient Logistics & Planning Knowledge - Basic Computer Skills / Microsoft Office - Proficient Financial Acumen - Basic PCP Level: N/A 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. BD is committed to providing a robust set of value-based programs and resources that are best-in-class, market-competitive and affordable for all associates and their families. Competitive pay Access a portion of your pay before pay day with DailyPay Healthcare coverage: No paycheck contributions for eligible associates under a certain salary threshold enrolled in the HSA Basic Medical Plan option, no matter how many dependents you cover. Preventive care covered at 100%. Dental and vision insurance at group rates. Paid parental leave up to 6 weeks Adoption assistance plan 401(k) plan with 75 cents on the dollar matched by BD up to 6% of compensation Company paid basic life and AD&D insurance Tuition reimbursement Discounted home, auto and pet insurance Paid holidays and vacation (pro-rated the first year based on actual start date) All benefits and policies are subject to eligibility and enrollment requirements. Most coverage begins on your first day or the date you become eligible for benefits. 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 NE - Columbus (West) Additional LocationsWork Shift

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: R&D Product Development Job Sub Function: Biomedical Engineering Job Category: Scientific/Technology All Job Posting Locations: Cincinnati, Ohio, United States of America Job Description: Ethicon (Johnson & Johnson) is currently recruiting for a Quality Engineering Leader. This position will be located in Cincinnati, Ohio. About MedTech Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech Key Responsibilities: Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines: * The candidate will oversee both Harmonic and Advanced Bipolar divisions within lifecycle and have 3-5 direct reports. * Supports the continuous improvement of quality systems to facilitate business and quality objectives, and compliance review and resolution processes. * Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business. * Oversees the quality engineering group to implement engineering and quality systems, and regulatory compliance strategies and objectives. * Conducts basic technical design reviews and facilitates the implementation and utilization of quality tools within research and development and new product development. * Directs the work assignments of engineers to support effective quality engineering processes at all levels and throughout the engineering organization. * Oversees engineers in development and deployment of innovative quality engineering tools, techniques and systems. * Oversees the implementation of changes with focus on business results including prevention and detection of defects at earliest phase of product design, continuous improvement and customer satisfaction. * Performs design reviews and pre-validation assessments to ensure the safe and environmentally sound startup of new processes. * Assures compliance with all local government and company regulations, policies and procedures. * Provides statistical support for design of experiments, sampling plans, capability assessments, and hypothesis tests. * Research and report on competitors' design strengths and weaknesses. * Provides technical expertise across a broad range of engineering areas and methodologies. Qualifications Education: * Bachelors degree or equivalent in Science, Engineering, Technology or Math is required; Masters degree or equivalent is preferred Experience and Skills: Required: * A minimum of 6 years of related work experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) or veterans with leadership experience * Advanced knowledge of Quality Engineering/Scientific methods and techniques * Applied statistics of growing complexity * Test method development, statistics, and reliability * Experience working within a team, acquiring feedback, negotiating, and training * Understand new concepts quickly, research and maintain ongoing learning of industry regulations * Fundamental technical understanding of manufacturing equipment and processes * Experience implementing and/or maintaining production and process controls using appropriate techniques (for example: process capability measures, statistical process controls, and process performance metrics) Preferred: * Knowledge of: Regulatory compliance, GMPs, MDR, 510K (Pre-market Notification), PMA (Pre-market Approval), and Government, trade association, industry & medical publications * An ASQ certification (CQE, CQM, CRE or CQA) * Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification * Project management (supporting multiple projects at a time) and the ability to work with simultaneous priorities in a matrixed environment * Experience with Risk Management (ISO 14971), Medical Device Quality Management Systems (ISO 13485) and Advanced Quality Systems (AQS) * Apply and execute Quality System processes (CAPA, NCR, Risk Management, Design Control, Change Control) Other: * Up to 10% of both domestic and international travel is required Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Bioinformatics, Biological Engineering, Biostatistics, Coaching, Critical Thinking, Design of Experiments (DOE), Healthcare Trends, Industry Analysis, Innovation, Medicines and Device Development and Regulation, Product Development, Relationship Building, Research and Development, Researching, SAP Product Lifecycle Management, Standard Scientific Processes and Procedures, Technologically Savvy The anticipated base pay range for this position is : $109,000.00 - $174,800.00 Additional Description for Pay Transparency: The expected base pay range for this position is $94,000 to $151,800 Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** R&D Product Development **Job Sub** **Function:** Biomedical Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** Cincinnati, Ohio, United States of America **Job Description:** Ethicon (Johnson & Johnson) is currently recruiting for a **Quality Engineering Leader** . This position will be located in **Cincinnati, Ohio.** **About MedTech** Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech **Key Responsibilities:** Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines: + The candidate will oversee both Harmonic and Advanced Bipolar divisions within lifecycle and have 3-5 direct reports. + Supports the continuous improvement of quality systems to facilitate business and quality objectives, and compliance review and resolution processes. + Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business. + Oversees the quality engineering group to implement engineering and quality systems, and regulatory compliance strategies and objectives. + Conducts basic technical design reviews and facilitates the implementation and utilization of quality tools within research and development and new product development. + Directs the work assignments of engineers to support effective quality engineering processes at all levels and throughout the engineering organization. + Oversees engineers in development and deployment of innovative quality engineering tools, techniques and systems. + Oversees the implementation of changes with focus on business results including prevention and detection of defects at earliest phase of product design, continuous improvement and customer satisfaction. + Performs design reviews and pre-validation assessments to ensure the safe and environmentally sound startup of new processes. + Assures compliance with all local government and company regulations, policies and procedures. + Provides statistical support for design of experiments, sampling plans, capability assessments, and hypothesis tests. + Research and report on competitors' design strengths and weaknesses. + Provides technical expertise across a broad range of engineering areas and methodologies. **Qualifications** **Education:** + Bachelors degree or equivalent in Science, Engineering, Technology or Math is required; Masters degree or equivalent is preferred **Experience and Skills:** **Required:** + A minimum of 6 years of related work experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) or veterans with leadership experience + Advanced knowledge of Quality Engineering/Scientific methods and techniques + Applied statistics of growing complexity + Test method development, statistics, and reliability + Experience working within a team, acquiring feedback, negotiating, and training + Understand new concepts quickly, research and maintain ongoing learning of industry regulations + Fundamental technical understanding of manufacturing equipment and processes + Experience implementing and/or maintaining production and process controls using appropriate techniques (for example: process capability measures, statistical process controls, and process performance metrics) **Preferred:** + Knowledge of: Regulatory compliance, GMPs, MDR, 510K (Pre-market Notification), PMA (Pre-market Approval), and Government, trade association, industry & medical publications + An ASQ certification (CQE, CQM, CRE or CQA) + Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification + Project management (supporting multiple projects at a time) and the ability to work with simultaneous priorities in a matrixed environment + Experience with Risk Management (ISO 14971), Medical Device Quality Management Systems (ISO 13485) and Advanced Quality Systems (AQS) + Apply and execute Quality System processes (CAPA, NCR, Risk Management, Design Control, Change Control) **Other:** + Up to 10% of both domestic and international travel is required Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . Internal employees contact AskGS to be directed to your accommodation resource. **Required Skills:** **Preferred Skills:** Bioinformatics, Biological Engineering, Biostatistics, Coaching, Critical Thinking, Design of Experiments (DOE), Healthcare Trends, Industry Analysis, Innovation, Medicines and Device Development and Regulation, Product Development, Relationship Building, Research and Development, Researching, SAP Product Lifecycle Management, Standard Scientific Processes and Procedures, Technologically Savvy **The anticipated base pay range for this position is :** $109,000.00 - $174,800.00 Additional Description for Pay Transparency: The expected base pay range for this position is $94,000 to $151,800 Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: R&D Product Development Job Sub Function: Biomedical Engineering Job Category: Scientific/Technology All Job Posting Locations: Cincinnati, Ohio, United States of America, Danvers, Massachusetts, United States of America, Irvine, California, United States of America, Raritan, New Jersey, United States of America Job Description: J&J MedTech is recruiting for a Senior Quality Engineer located in Cincinnati, OH. The role of a Senior Quality Engineer at J&J MedTech is to apply the principles of engineering, mathematics, statistics, organizational excellence, and risk management to help the company achieve two major objectives in support of the J&J Credo: * Meet and exceed the expectations of our customers * Achieve and maintain compliance with regulatory expectations The Senior Quality Engineer provides overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products, and ensures compliance to good manufacturing practices, international organization for standardization and any other applicable standards. Depending on job needs, a Senior Quality Engineer may work in: * New product development / new product introduction / new process introduction * Supply chain (life cycle engineering, manufacturing, assembly, or supplier quality) * Quality systems and business processes Key Job Responsibilities: Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: * Provides leadership in design and implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the product * Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes; acts as technical liaison, as needed, between product development, manufacturing, external manufacturers, and suppliers * Reviews and edits all engineering documentation related to assigned projects, such as technical reports, work instructions and method and process validation; provides review and approval for the release of new products and design changes ensuring quality requirements are met * Applies intermediate Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, and industry best practices to assignments. * Plans and conducts projects and assignments with technical responsibility or strategic input. Receives intermittent, moderately detailed instructions from technical Quality leaders at various levels, in addition to other stakeholders. * Addresses and corrects product and process complaints through data analysis, continuous product improvement, and/or corrective and preventive actions * Communicates business related issues or opportunities to next management level * Oversees audits of quality system categories to assess compliance to process excellence standards * Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management which outline findings * Performs and/or oversees complex hands-on and simulated testing for design verification and test method developments; inspects and oversees testing of prototypes, tools, and fixtures after fabrication to ensure that they meet specifications * Studies specifications, engineering blueprints, tool orders, and shop data and confers with engineering and shop personnel to resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost * Ensures personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures * Performs other duties assigned as needed * May support technical training (i.e. statistics and quality methods) and teaching/mentoring of others Key Skill and Knowledge Requirements: * Candidate must have strong analytical problem-solving skills and be able to contribute to or lead root cause investigations using various problem solving techniques and tools, and assess effectiveness of corrective actions * Candidate must have sound statistical application in areas such as DOE, sampling techniques, regression, reliability, FMEA, hypothesis testing, etc. * Experience with project management and the ability to work with multiple simultaneous priorities in a highly matrixed environment is required * Demonstrated experience working within a team, obtaining feedback, negotiating, and positively influencing is required * Ability to understand new concepts quickly, research and maintain ongoing learning of industry regulations is required * Fundamental technical understanding of manufacturing equipment and processes is preferred * Prior experience working with Risk Analysis and Risk Management is also preferred * Advanced quality systems (AQS) experience preferred * Knowledge of: Regulatory compliance, GMPs, MDD (Medical Devices Directive), 510K (Pre-market Notification), PMA (Pre-market Approval), and Government, trade association, industry & medical publications desired. Qualifications: * A bachelor's degree in engineering from an accredited engineering or relevant science/technical school is required. A degree in Mechanical, Electrical, Biomedical or other equivalent technical degree is preferred. * Non-STEM graduates with follow-on technical training or experience will also be considered. Appropriate relevant advanced degrees are preferred. * Generally requires minimum of 4 years' work experience. Experience in a regulated industry or veterans with leadership experience will be given preference. * Experience with Risk Management (ISO 14971), Medical Device Quality Management System (ISO 13485), Gage repeatability and reproducibility theory and application, statistics, project management (supporting multiple projects simultaneously), and reliability is strongly preferred. * Auditing skills such as - ISO, QSR (Quality Systems Regulations), MDSAP, and GMP standards are preferred. * An ASQ certification (CQE, CQM, CRE or CQA) is an asset. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset. This position will be located in Cincinnati, OH and may have up to 10% of both domestic and international travel. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers .Internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Problem Solving Preferred Skills: Analytical Reasoning, Bioinformatics, Biological Engineering, Biological Sciences, Biostatistics, Coaching, Data Savvy, Detail-Oriented, Feasibility Studies, Inventory Management, Preclinical Research, Project Schedule, Prototyping, Research and Development, Researching, SAP Product Lifecycle Management, Technologically Savvy The anticipated base pay range for this position is : $92,000.00 - $148,350.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** R&D Product Development **Job Sub** **Function:** Biomedical Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** Cincinnati, Ohio, United States of America, Danvers, Massachusetts, United States of America, Irvine, California, United States of America, Raritan, New Jersey, United States of America **Job Description:** J&J MedTech is recruiting for a Senior Quality Engineer located in Cincinnati, OH. The role of a Senior Quality Engineer at J&J MedTech is to apply the principles of engineering, mathematics, statistics, organizational excellence, and risk management to help the company achieve two major objectives in support of the J&J Credo: + Meet and exceed the expectations of our customers + Achieve and maintain compliance with regulatory expectations The Senior Quality Engineer provides overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products, and ensures compliance to good manufacturing practices, international organization for standardization and any other applicable standards. Depending on job needs, a Senior Quality Engineer may work in: + New product development / new product introduction / new process introduction + Supply chain (life cycle engineering, manufacturing, assembly, or supplier quality) + Quality systems and business processes Key Job Responsibilities: Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: + Provides leadership in design and implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the product + Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes; acts as technical liaison, as needed, between product development, manufacturing, external manufacturers, and suppliers + Reviews and edits all engineering documentation related to assigned projects, such as technical reports, work instructions and method and process validation; provides review and approval for the release of new products and design changes ensuring quality requirements are met + Applies intermediate Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, and industry best practices to assignments. + Plans and conducts projects and assignments with technical responsibility or strategic input. Receives intermittent, moderately detailed instructions from technical Quality leaders at various levels, in addition to other stakeholders. + Addresses and corrects product and process complaints through data analysis, continuous product improvement, and/or corrective and preventive actions + Communicates business related issues or opportunities to next management level + Oversees audits of quality system categories to assess compliance to process excellence standards + Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management which outline findings + Performs and/or oversees complex hands-on and simulated testing for design verification and test method developments; inspects and oversees testing of prototypes, tools, and fixtures after fabrication to ensure that they meet specifications + Studies specifications, engineering blueprints, tool orders, and shop data and confers with engineering and shop personnel to resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost + Ensures personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures + Performs other duties assigned as needed + May support technical training (i.e. statistics and quality methods) and teaching/mentoring of others Key Skill and Knowledge Requirements: + Candidate must have strong analytical problem-solving skills and be able to contribute to or lead root cause investigations using various problem solving techniques and tools, and assess effectiveness of corrective actions + Candidate must have sound statistical application in areas such as DOE, sampling techniques, regression, reliability, FMEA, hypothesis testing, etc. + Experience with project management and the ability to work with multiple simultaneous priorities in a highly matrixed environment is required + Demonstrated experience working within a team, obtaining feedback, negotiating, and positively influencing is required + Ability to understand new concepts quickly, research and maintain ongoing learning of industry regulations is required + Fundamental technical understanding of manufacturing equipment and processes is preferred + Prior experience working with Risk Analysis and Risk Management is also preferred + Advanced quality systems (AQS) experience preferred + Knowledge of: Regulatory compliance, GMPs, MDD (Medical Devices Directive), 510K (Pre-market Notification), PMA (Pre-market Approval), and Government, trade association, industry & medical publications desired. **Qualifications:** + A bachelor's degree in engineering from an accredited engineering or relevant science/technical school is required. A degree in Mechanical, Electrical, Biomedical or other equivalent technical degree is preferred. + Non-STEM graduates with follow-on technical training or experience will also be considered. Appropriate relevant advanced degrees are preferred. + Generally requires minimum of 4 years' work experience. Experience in a regulated industry or veterans with leadership experience will be given preference. + Experience with Risk Management (ISO 14971), Medical Device Quality Management System (ISO 13485), Gage repeatability and reproducibility theory and application, statistics, project management (supporting multiple projects simultaneously), and reliability is strongly preferred. + Auditing skills such as - ISO, QSR (Quality Systems Regulations), MDSAP, and GMP standards are preferred. + An ASQ certification (CQE, CQM, CRE or CQA) is an asset. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset. **This position will be located in Cincinnati, OH and may have up to 10% of both domestic and international travel.** _Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act._ _Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via_ _*******************/contact-us/careers_ _.Internal employees contact AskGS to be directed to your accommodation resource._ **Required Skills:** Problem Solving **Preferred Skills:** Analytical Reasoning, Bioinformatics, Biological Engineering, Biological Sciences, Biostatistics, Coaching, Data Savvy, Detail-Oriented, Feasibility Studies, Inventory Management, Preclinical Research, Project Schedule, Prototyping, Research and Development, Researching, SAP Product Lifecycle Management, Technologically Savvy **The anticipated base pay range for this position is :** $92,000.00 - $148,350.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************

Title: Development Process Engineer Duration: 12 Month 100% Onsite Description: This position applies a combination of Process Engineering, Laboratory and Food Science expertise using small scale ingredient / product characterization techniques and a “hands on” approach to support New Product Development, Ingredient Qualification/Surveillance and Plant Root Cause Analysis needs. Qualifications & Education: Desired min 0-2 years of relevant experience. Mechanical understanding to operate and troubleshoot pilot scale equipment. Background in / knowledge of functional ingredient manufacturing processes (e.g. proteins, emulsifiers) and food science is advantageous. Manufacturing Plant, Laboratory and/or R&D Pilot Plant / Scalability Experience an advantage. Strong organizational and interpersonal skills and ability to interface with cross functional technical teams. Disciplined and adaptable to work on a variety of projects. Interest in or knowledge of the impact of processing parameters on ingredients and finished product quality. Ability to effectively analyze and summarize data (using statistical methods) Education Requirements - B.S. in Engineering, B.S. qualification in Food Science/Food Chemistry also relevant. Primary role: The primary function is to design and perform routine Design of Experiments for small scale process characterization and associated testing to support the Process Innovation Characterization Wet Facility objectives. This facility provides small scale wet batching, processing and test services to Supply Chain and Research and Development A person in this position must be able to work independently to carry out trials/experiments and to generate scientifically valid data. Collaborate closely with team site SPOC's (single point of contact) and cross functional partners (PR&D Pilot Plant, Developers, Analytical, Site Tech Centers, Material Value Stream) Support product Root Cause Analysis activities Characterization of key functional ingredients Support Abbott Nutrition manufacturing sites in exploring opportunities to proactively optimize current bottles necks. Product & Process formats: Liquids and Powders Wet Batching, Aseptic Processing/filling, Evaporation, Drying, Dry Blending Responsibilities include: Design, execute and report outcomes from very small-scale process, ingredient and full product characterization tests working with cross-functional technical partners Operate and clean small pilot scale equipment, UHT, fill hood, evaporator. Follow Abbott Laboratory Housekeeping and EH&S best practices Manage lab work reservation calendar, supporting multiple, often concurrent, projects and meet assigned deadlines. Establish and maintain facility Standard Operating Procedures as required. Establish and maintain characterization database for selected ingredients and products Ensure the necessary preventative maintenance schedule is in place and executed per plan, liaise with relevant contractors. Collate trial data and perform analysis, reaching technical conclusions, preparing and communicating recommendations. Be assigned as Process Innovation lead on selected projects Provide effective communication through verbal and written reports (using approved templates), timely weekly updates, and knowledge sharing. Consultants Eligible Benefits Upon Waiting Period: Medical and Prescription Drug Plans Dental Plan Vision Plan Health Savings Account (for High-Deductible Health Plans) Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit) Supplemental Life Insurance Short Term Disability (coverage varies by state) Long Term Disability Critical Illness, Hospital coverage, Accident Insurance MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance 401(k) Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:Main Purpose of the Role Provides support to the Manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes, and to ensure that production goals are met. Monitors performance of equipment, machines and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields or product quality issues. Interfaces with Quality and Research and Development organizations to integrate new products or processes into the existing manufacturing area. Main Responsibilities Initiates and completes technical activities leading to new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company. • Prepares reports, publishes, and makes presentations to communicate findings. • Analyzes and solves problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology. Apply standard engineering principles and methodologies to interpret problems; create/modify designs; draw conclusions and recommend options for solutions; • Understands engineering principles theories, concepts, practices and techniques. Develops knowledge in a field to become a recognized leader or authority in an area of specialization and applies this knowledge in leadership roles in the company. • Incorporates business policies and procedures into task completion. Responsible for completing documentation in a timely manner and in accordance with business standards; • Understands the business needs of the company, and has knowledge of the customer needs of our business. • Understands the business cycle and foresight of emerging technologies trends. Responsible for implementing and maintaining the effectiveness of the Quality System. • Cultivates internal and external network of resources to complete tasks. • Serves has a resource in the selection orientation and training of new engineers and employees. • May lead a project team, determining goals and objectives for the projects. Execute work instruction updates to ensure that documents accurately reflect the current process. • Mentors employees by sharing technical expertise and providing feedback and guidance. • Interacts cross functionally and with internal and external customers. • Serves as a consultant for engineering or scientific interpretations and advice on significant matters. • Acts as a spokesperson to customers on business unit current and future capabilities. • Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks. • Strong project management skills. Provides guidance to less experienced staff. Acts as a mentor to lower level individual contributors. • Influence exerted at peer level and occasionally at first levels of management. • Plans, organizes, and prioritizes own daily work routine to meet established schedule. Responsible for writing and evaluating process, equipment, and non-product software qualifications. • Exercises authority and judgment within defined limits to determine appropriate action. • Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources. REQUIREMENTS Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment. Minimum 2 years 2-5 years of related work experience with a good understanding of specified functional area. Education Bachelors Degree (± 16 years) Related field. OR An equivalent combination of education and work experience Masters Degree (± 18 years) Preferred The base pay for this position is $60,000.00 - $120,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY:EngineeringDIVISION:CRM Cardiac Rhythm ManagementLOCATION:United States > Avon : 10207 Veterans DriveADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 5 % of the TimeMEDICAL SURVEILLANCE:NoSIGNIFICANT WORK ACTIVITIES:Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work in a clean room environment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************

Career CategoryProcess DevelopmentJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Packaging Equipment Engineer- Process Development/NPI What you will do Let's do this. Let's change the world. In this role you as a member of the Amgen Ohio, Process Development organization, this role serves as project manager and technical expert for Final Drug Product New Process Introductions (NPI) into Amgen Ohio. NPI scope may include the implementation of various drug product formats (e.g. vial, syringe, auto injectors, etc.), introduction of new processes and equipment (including medical device final assembly and testing), and implementation of new packaging configurations. The Senior Engineer engages Drug Product development teams throughout the commercialization process, leading multi-functional NPI teams with support from Manufacturing, Supply Chain, Quality, Engineering, Capital Projects, Process Development and other business groups. Primary responsibilities include leading the NPI's for necessary process, facility, equipment, materials, and training modifications; development of project execution plans; ensuring process requirements are effectively transferred into manufacturing; and coordination/execution of NPI activities, which may include document preparation or revision, change control management, manufacturing process modifications, equipment and technology implementation (design through qualification), and supporting manufacturing readiness activities. Work with various NPI support groups to develop, maintain, and implement the NPI project plan. Senior Engineer will function as the NPI project manager and is accountable for NPI scope, schedule, resources, and risk management. Responsibilities include issue resolution in a timely manner and partner concern to different levels of management as appropriate. Engage with network partners to develop process and technology strategies that achieves clinical/commercial development schedules while minimizing transfer risks. Collaborate with Combination Product Operations, Quality, and Regulatory partners to manage change control processes and respond to regulatory questions and/or audit findings within the scope of the NPI. Support generation, revision, review, execution, and approval of relevant technical documents (e.g., manufacturing procedures, protocols, training materials, design control deliverables, and specifications). Ensure design/process transfer requirements are appropriately implemented and aligned with current manufacturing strategies. Support a safe working environment by staying in sync with all pertinent environmental health/safety practice, rules and regulations. Lead and manage change control processes for New Product Introductions (NPI), ensuring timely approvals, regulatory compliance, and seamless implementation across cross-functional teams. Monitor and track NPI-related changes to ensure proper risk assessment, mitigation strategies, and alignment with project timelines. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek will possess these qualifications. Basic Qualifications: Doctorate degree Or Master's degree and 2 years of Process Development, Engineering, or NPI experience Or Bachelor's degree and 4 years of Process Development, Engineering, or NPI experience Or Associate's degree and 8 years of Process Development, Engineering, or NPI experience Or High school diploma / GED and 10 years of Process Development, Engineering, or NPI experience What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. . Salary Range 119,195.00 USD - 147,867.00 USD

**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. **Senior Packaging Equipment Engineer- Process Development/NPI** **What you will do** Let's do this. Let's change the world. In this role you as a member of the Amgen Ohio, Process Development organization, this role serves as project manager and technical expert for Final Drug Product New Process Introductions (NPI) into Amgen Ohio. NPI scope may include the implementation of various drug product formats (e.g. vial, syringe, auto injectors, etc.), introduction of new processes and equipment (including medical device final assembly and testing), and implementation of new packaging configurations. The Senior Engineer engages Drug Product development teams throughout the commercialization process, leading multi-functional NPI teams with support from Manufacturing, Supply Chain, Quality, Engineering, Capital Projects, Process Development and other business groups. Primary responsibilities include leading the NPI's for necessary process, facility, equipment, materials, and training modifications; development of project execution plans; ensuring process requirements are effectively transferred into manufacturing; and coordination/execution of NPI activities, which may include document preparation or revision, change control management, manufacturing process modifications, equipment and technology implementation (design through qualification), and supporting manufacturing readiness activities. Work with various NPI support groups to develop, maintain, and implement the NPI project plan. Senior Engineer will function as the NPI project manager and is accountable for NPI scope, schedule, resources, and risk management. Responsibilities include issue resolution in a timely manner and partner concern to different levels of management as appropriate. + Engage with network partners to develop process and technology strategies that achieves clinical/commercial development schedules while minimizing transfer risks. + Collaborate with Combination Product Operations, Quality, and Regulatory partners to manage change control processes and respond to regulatory questions and/or audit findings within the scope of the NPI. + Support generation, revision, review, execution, and approval of relevant technical documents (e.g., manufacturing procedures, protocols, training materials, design control deliverables, and specifications). + Ensure design/process transfer requirements are appropriately implemented and aligned with current manufacturing strategies. + Support a safe working environment by staying in sync with all pertinent environmental health/safety practice, rules and regulations. + Lead and manage change control processes for New Product Introductions (NPI), ensuring timely approvals, regulatory compliance, and seamless implementation across cross-functional teams. + Monitor and track NPI-related changes to ensure proper risk assessment, mitigation strategies, and alignment with project timelines. **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek will possess these qualifications. **Basic Qualifications:** Doctorate degree **Or** Master's degree and 2 years of Process Development, Engineering, or NPI experience **Or** Bachelor's degree and 4 years of Process Development, Engineering, or NPI experience **Or** Associate's degree and 8 years of Process Development, Engineering, or NPI experience **Or** High school diploma / GED and 10 years of Process Development, Engineering, or NPI experience **What you can expect from us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: + A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts + A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan + Stock-based long-term incentives + Award-winning time-off plans + Flexible work models, including remote and hybrid work arrangements, where possible **Apply now and make a lasting impact with the Amgen team.** **careers.amgen.com** In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.