Quality Engineer – pharma company Cambridge (Hybrid – 2.5 days onsite per week) Contract Rate £28.20 per hour (PAYE) + holiday entitlement
Atrium (EMEA) is partnering with a leading global biopharma organisation to hire a Quality Engineer. The candidate will provide design control and risk management subject matter expertise to medical device and combination product development programmes throughout the product lifecycle.
Lead design control and risk management activities for product development programmes Ensure compliance with regulatory and quality standards (ISO, FDA, EU MDR) Prepare and review design history files and risk management documentation Support design validation activities, including human factors engineering Contribute to regulatory submissions and audit readiness Assist with device investigations for clinical and commercial products
Degree (BSc/MSc/PhD) in Engineering, Life Sciences, or related discipline Experience in medical devices or combination products Experience of writing regulatory submissions, specifically BLA, NDA and NbOP. Extensive knowledge of device design controls, human factors and risk management. Strong knowledge of design controls & risk management EU Medical Devices Regulation Understanding of Human Factors / Usability Engineering Knowledge of GMP and quality systems
Work with a world-renowned pharmaceutical organisation…