Quality Engineer II

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. 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. What You’ll Work On Drive 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. Review and approve engineering changes in a timely manner. Collaborate with R&D and Marketing to support mobile app deployment activities (for Software as a Medical Device projects). Drive alignment during cross‑functional review and approval of impact assessments, root‑cause analysis investigation and resolution activities. Review and approve batch records for products used in design verification/validation testing and clinical investigations. Ensure Device History File (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and procedures. Collect, organize, and monitor information related to quality and process improvement. Participate in internal & external audits and ensure audit responses are submitted in a timely manner. Required Qualifications Minimum 5 years of applicable technical/engineering experience and demonstrated use of quality tools/methodologies. Minimum 2 years in a regulated environment such as medical devices, pharmaceutical products, food manufacturing, aerospace, or automotive. 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 a bachelor’s degree. Recognition as a great place to work in dozens of countries, named one of the most admired companies by Fortune. Commitment to diversity, working mothers, female executives, and scientists. Approvals & EEO Statement Abbott is an Equal Opportunity Employer, committed to employee diversity. Compensation The base pay for this position is $90,000.00 – $180,000.00. In specific locations, the pay range may vary from the range posted. #J-18808-Ljbffr