Sr Quality Engineer II - Combination Products

Role: Lead Quality Engineer for medical device combination products, focusing on design controls, risk management, and lifecycle quality oversight. Responsibilities: partner with Device Engineering on development activities, ensure compliance with FDA, ISO, and Gilead quality standards, lead quality improvement initiatives, resolve complex technical and quality issues with cross-functional teams and CMOs, support change control assessments, and develop controlled documentation. Qualifications: Bachelor's in Engineering or scientific discipline with ≥8 years (Master's with ≥6 years) of relevant QA experience, with strong background in medical devices and combination products. Preferred: 10+ years supporting combination products like autoinjectors or pre-filled syringes, expertise in design controls, risk management (ISO 14971), statistical methods, process improvement, and manufacturing operations. HighValue: medical device/combination product focus, lifecycle management, design verification/validation, risk management, regulatory compliance, and cross-functional collaboration. WorkSetup: Not specified.