QA Engineer

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 109,000 colleagues serve people in more than 160 countries.At Abbott Diabetes Care, we believe people with diabetes should have the freedom to enjoy active lives. That''s why we''re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We''re revolutionizing the way people monitor their glucose levels with our new sensing technology.Our Sustaining QA Department at Division HQs location in Alameda, CA currently has an opportunity for a ''product-focused'' Quality Assurance Engineer III. The primary purpose of this role is to serve as the primary Quality Assurance / QA representative on new product design and on-market development / change teams. This position is critical in assuring compliance with applicable standards/requirements, and the ability to successfully meet the business needs and objectives. You''ll build and maintain successful cross-functional relationships with internal departments such as R&D Engineering, Operations, Quality and Regulatory Affairs. Provides support to Clinical Material Release, Quality Control, and Calibration programs.WHAT YOU''LL DO• Perform as a Subject Matter Expert with a comprehensive knowledge in the area of Good Manufacturing Practices (GMP).• Monitor and report to upper management on design control related projects:a. Project planning issuesb. Compliance Activities (DHF Audits, Traceability, etc.)c. 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 [CAPA] as it applies design control activities.EDUCATION AND EXPERIENCE YOU''LL BRINGRequired / Minimum Qualifications:• Bachelors Degree in Engineering, Life Sciences, or Physical Sciences• 5 years of professional work experience in the field of Quality Assurance, Technical Quality, or equivalent• 3 years of professional work experience in the Medical Device manufacturing industryPreferred Qualifications:• Knowledge in the areas of Design Controls, VV activities, manufacturing practices or processes, and statistical techniques• Knowledge of applicable regulations and standards such as FDA, QSR and ISO regulations• Excellent attention to detail and accuracy. Analysis/Critical thinking/Problem-solving skills.• Good communication and written skills, and interpersonal skills to build strong cross functional working relationships. • Ability to work effectively independently and in cross functional team environment.• Ability to successfully balance and prioritize multiple ongoing projects/tasks.• Able to deliver quality outputs under minimal supervision.• Strong technical writing skills to capture complex technical requirements, cause/effect, and risks in design plans, qualifications, FMEAs and investigations.• Strong verbal communications to work with engineers, quality and global operations team members to ensure compliance to division policies.WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer:• A fast-paced work environment where your contribution is essential to success• 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• Paid time off• 401(k) retirement savings with a generous company match• The stability of a company with a record of strong financial performance and history of being actively involved in local communitiesLearn more about our benefits that add real value to your life to help you live fully: your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

Created: 2021-11-29