Quality Engineer III
Abbott Laboratories Alameda
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.
Working at Abbott
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’ll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
- An excellent retirement savings plan with high employer contribution
- 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 Opportunity
The Quality Engineer III will serve as the primary QA representative on new product design and on-market development / change teams. Build and maintain successful cross functional relationships with internal departments such as R&D Engineering, Operations, Quality and Regulatory Affairs.Provide support, as needed, to Clinical Material Release, Quality Control, and Calibration programs.
What You’ll Work On- Monitor and report to upper management on design control related projects.
- Project planning issues
- Compliance Activities (DHF Audits, Traceability, etc.)
- Verification and Validation Status
- Participate in continuous improvement initiatives as appropriate for the design control system.
- Assist in the development, approval, and change control of design history documentation (e.g. Design Inputs, Design Outputs, Trace Matrix, Design Verification/Validation, Change Impact Assessments, Quality Plans, Work Instructions, Protocols, Reports, FMEAs, etc.)
- Monitor and maintain DHF requirements in accordance with project timeline and design control requirements.
- Actively engage with Operations and Engineering to implement design control deliverables.
- Collect and analyze quality information/data from various quality systems and develop reports, make data driven recommendation/decisions, take appropriate action based on the trends, communicate/report activities and status as needed for senior management review.
- Conduct or assist in systems/process/product failure mode and effects analysis and initiation of corrective and/or preventative action as it applies design control activities.
- Bachelors Degree (± 16 years) Engineering, Life Sciences, or Physical Sciences
- Minimum 5 years Quality Assurance, Technical Quality, or equivalent
- Minimum 3 years medical device manufacturing industry
- Some Knowledge in the areas of Design Controls, VV activities, manufacturing practices or processes, and statistical techniques
- Some knowledge applicable regulations and standards such as FDA, QSR and ISO regulations
- Knowledge and experience with medical device regulations for device class (IIb and III) including combination products (device + drug):
- US Food and Drug Administration 21CFR 820 and 11, US FDA cGMP, 21 CFR 210, 211, and 21CFR Part 4.
- MDSAP, ISO 9001, ISO 13485, ISO 14971, IEC 62304.
- In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC. Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.
- Quality Management Systems (QMS), Risk and Cybersecurity Management, and CAPA Management.
- Self-starter taking initiative to begin projects, volunteers for new or difficult tasks, and works with little to no supervision.
- Promotes collaboration among peers and cross functional groups to work collectively by encouraging teamwork and taking risks for finding feasible solutions to problems.
- Mentors and coach colleagues/cross functional team members to share product and QMS/QA knowledge and assist with training.
- Leads initiatives to collaborate and brainstorm with colleagues/cross functional team members to find solutions for challenging and complex issues.
- Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
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 www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $95,500.00 – $190,900.00. In specific locations, the pay range may vary from the range posted.
Abbott LaboratoriesPleasanton (CA), 24 mi from Alameda (CA)
nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
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