Quality Assurance Engineer II

Abbott • Alameda, CA

7d • Onsite

About The Position

The Quality Assurance Engineer II position works out of our Alameda, CA location in the Diabetes Care Division. 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. This position is responsible for activities related to design control; qualification; specification and corrective and preventative action of medical devices, including software as a medica device (SaMD), in-vitro, diagnostic devices, consumer devices, and accessories. Lead/support design planning efforts to include heading CFTs; establishing deliverables and tracking completion for complex projects. Support complex investigations and CAPA activities.

Requirements

• BS in engineering or related field (Mechanical or Biomedical preferred)
• 3+ years of Quality experience, ideally within Design Controls - Design for Manufacturability
• Prior Medical Device industry experience
• Statistical Analysis experience
• Calibration/Preventative Maintenance experience

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

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
• Excellent retirement savings plan with a high employer contribution
• Tuition reimbursement
• Freedom 2 Save student debt program
• FreeU education benefit

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level