Sr Quality Engineer II - 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 (Combination Products)
Builds
Medical device combination products (e.g., autoinjectors, pre-filled syringes, co-packaged kits)
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design controls, Risk management (ISO 14971), FDA 21 CFR Part 820 & 4 compliance, ISO 13485, Lifecycle quality oversight, Change control evaluation, Documentation development
Preferred skills
Project management, Process improvement, Statistical methods (capability analysis, MSA, Gage R&R), Hazard analysis, FMEA, System-level risk analysis
Technologies
FDA 21 CFR Part 820, ISO 13485, ISO 14971
Responsibilities
Partner with Device Engineering on design verification, validation, and technology transfer; Interface with contract manufacturers and suppliers to resolve complex quality issues; Act as escalation point for high-impact quality issues; Provide quality guidance for change controls and impact assessments; Develop and approve controlled documentation including protocols, plans, and risk analyses.
Seniority
Senior, hands-on IC
