QA Engineer
Core
Lead design control and risk management activities for medical device and combination product development programmes throughout the product lifecycle.
Role type
Quality Engineer (Medical Devices)
Builds
Medical device and combination product development programmes
Domain
Biopharma / Medical Devices
Deliverable
client delivery
Required skills
Design control, Risk management, Regulatory submissions (BLA, NDA, NbOP), Human factors engineering, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR Part 4, EU MDR, GMP
Preferred skills
Experience in medical devices or combination products, Knowledge of device design controls
Technologies
ISO 13485, ISO 14971, 21 CFR 820, 21 CFR Part 4, EU MDR
Responsibilities
Lead design control and risk management activities, Ensure compliance with regulatory and quality standards, Prepare and review design history files and risk management documentation, Support design validation activities including human factors engineering, Collaborate with external partners, suppliers, and manufacturing sites, Contribute to regulatory submissions and audit readiness, Assist with device investigations for clinical and commercial products
Seniority
Mid-level, hands-on IC
