Senior Medical Device Quality Engineer
Core
Ensure medical device products meet safety, regulatory, and quality standards from design through launch for combination products.
Role type
Senior Medical Device Quality Engineer (IC)
Builds
Medical device combination products (e.g., pre-filled syringes, autoinjectors) for patient use
Domain
Biopharmaceuticals / Medical Devices
Required skills
Design controls, Risk management (ISO 14971), Root cause analysis, CAPA management, Change controls, Process validation, Regulatory compliance (FDA 21 CFR 820, ISO 13485, EU MDR), Technical drawing review, Supplier quality management
Preferred skills
Advanced degree in engineering, Statistical tools (DOE, process capability), Regulatory submission support, Medical device software quality
Technologies
ISO 14971, ISO 13485, FDA 21 CFR part 820, EU MDR, Design and Development Files (DDF), Design History File (DHF)
Responsibilities
Oversee device design control activities from planning to commercial launch; Review/approve technical documentation and quality plans; Lead investigations for nonconformances, deviations, and complaints; Act as SME for regulatory inspections and audits; Partner with suppliers to resolve component quality issues
Seniority
Senior, hands-on IC