Quality Engineer II
About The Position
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. JOB DESCRIPTION: 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 Diabetes Care division where 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. As the Quality Engineer II you will be responsible for activities related to design control; qualification; specification and corrective and preventative action of medical devices, including software as a medical device (SaMD), in-vitro, diagnostic devices, consumer devices, and accessories. You will lead/support design planning efforts to include heading CFTs; establishing deliverables and tracking completion for complex projects. You will lead/support complex investigations and CAPA activities.
Requirements
- Minimum 5 years applicable technical/engineering experience and demonstrated use of Quality tools/methodologies.
- Minimum 2 years regulated environment such as medical devices, pharmaceutical products, food manufacturing, aerospace, or automotive.
Responsibilities
- Drives alignment in cross functional meetings acting as QA representative on new and on market product design projects to ensure compliance with the design control process.
- Reviews and approves engineering changes in a timely manner
- Collaborates with R&D and Marketing to support mobile app deployment activities (for Software as a Medical Device projects)
- Drives alignment during cross functional review and approval of impact assessments, root-cause analysis investigation and resolution activities
- Reviews and approves batch records for products used in design verification/validation testing and clinical investigations
- Ensures Device History File (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and procedures
- Collects, organizes, and monitors information related to quality and process improvement
- Participates in internal & external audits and ensures audit responses are submitted in a timely manner
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
Number of Employees
5,001-10,000 employees
