Sr. Quality Engineer I- Combination Products
Core
Lead Quality Engineer for medical device combination product development programs, focusing on design controls, risk management, and lifecycle quality oversight.
Role type
Senior IC Quality Engineer (Medical Devices/Combination Products)
Builds
Medical device combination products (e.g., autoinjectors, pre-filled syringes, co-packaged kits) for Gilead's therapeutic areas
Domain
Biopharmaceuticals / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design controls, Risk management (ISO 14971), Regulatory compliance (FDA 21 CFR Part 820/4, ISO 13485), Change control management, Documentation development, Cross-functional collaboration, Supplier/CMO interface
Preferred skills
Project management, Process improvement, Statistical methods (MSA, Gage R&R), FMEA, System-level risk analysis, Manufacturing operations knowledge
Technologies
FDA 21 CFR Part 820, ISO 13485, ISO 14971, Design History Files (DHF), Risk Management Files (RMF)
Responsibilities
Partner with Device Engineering on design verification, validation, and technology transfer; Plan and track quality improvement initiatives; Act as escalation point for high-impact quality issues; Provide guidance on change controls and impact assessments; Develop and approve controlled documentation including protocols, plans, and risk analyses.
Seniority
Senior, hands-on IC
