Sr. Quality Engineer I- Combination Products

Role: Lead Quality Engineer for medical device combination product development, focusing on design controls, risk management, and lifecycle quality oversight. Responsibilities: collaborate with Device Engineering on design verification, validation, and technology transfer; ensure compliance with FDA, ISO, and Gilead quality standards; lead quality improvement initiatives; interface with cross-functional teams, contract manufacturers, and suppliers to resolve technical and quality issues; act as escalation point for complex quality risks; support change control evaluations and documentation development. Qualifications: Bachelor's in Engineering or sciences with ≥6 years or Master's with ≥4 years of relevant QA experience; proven experience in medical device and drug-device combination products; strong communication skills. Preferred: ≥8 years supporting combination products (e.g., autoinjectors, pre-filled syringes), deep expertise in design controls, risk management, project management, statistical methods, and ISO 14971 risk practices; knowledge of manufacturing operations and global quality regulations. High-Value: focus on combination products, lifecycle management, risk assessment, design controls, GxP compliance, and cross-functional collaboration. Work setup and travel specifics are not detailed.