Quality Assurance Engineer III

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 Assurance Engineer III

Working at Abbott

At Abbott, You Can Do Work That Matters, Grow, And Learn, Care For Yourself And Your 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.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.
  
  

The Opportunity

The Quality Assurance 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.

This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday.

What You’ll Work On

• Monitor and report to upper management on design control related projects.
  
  

a. Project planning issues

b. 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 as it applies design control activities.
• Review, provide feedback to teams, and approve documentation required for the deliverables associated with the project design control files.
• Provide support to Quality Control activities ensuring timely release of components and/or product.
• Provide support to Site Equipment Calibration Program and serve as alternate Calibration Coordinator as required.
• Provide support to Site Validation Program to include master planning, periodic reviews, and review/approval of validation.
• Qualification documentation ensuring compliance to internal requirements and applicable regulations.
  
  

Required Qualifications

• Bachelors Degree in Engineering, Life Sciences or Physical Sciences. AA Degree plus 8 yrs of experience will be considered.
• Minimum 5 yrs experience in Quality Assurance, Technical Quality.
• Minimum 3 years experience in the medical device industry.
• Some knowledge in the areas of design controls, V&V activities, mfg practices/proceses and statistical techniques.
• Some applicable experience with regulations and standards such as FDA, QSR and ISO regulations.
  
  

Apply Now

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.

Divisional Information

Medical Devices

General Medical Devices

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

Diabetes

We’re focused on helping people with diabetes manage their health 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.

The base pay for this position is $98,000.00 – $196,000.00. In specific locations, the pay range may vary from the range posted.