Job description
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 115,000 colleagues serve people in more than 160 countries.
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
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
This position works out of our Alameda, CA location in the Abbott Diabetes Care Division, where we are 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.
What you’ll work on
- Serve as the QA representative on on-market development / change teams for Abbott's FreeStyle Libre and FreeStyle Libre Pro products
- Monitor 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
- 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
- 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.
Required Qualifications
- Bachelor’s Degree in one of the following areas: Engineering Life Sciences, or Physical Sciences.
- 3 years of experience in Quality Assurance, Technical Quality, or equivalent; Knowledge in the areas of Design Controls, VV activities, manufacturing practices or processes, and statistical techniques.
Preferred Qualifications
- Working knowledge applicable regulations and standards such as FDA, QSR and ISO regulations (62304, etc.) preferred
- Working knowledge of software programs (Python, R) preferred
- Demonstrated written, oral and interpersonal skills.
- Strong analytical skills, problem solving techniques and statistical application experience.
What We Offer
At Abbott, you can have a good job that can grow into a great career. We offer:
- 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 communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow 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 www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The salary for this role is between $82,100 – $164,100
About Abbott
CEO: Robert Ford
Revenue: $10+ billion (USD)
Size: 10000+ Employees
Type: Company - Public
Website: www.abbott.com
Year Founded: 1888