QA Engineer, Cambridgeshire

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.

Key Responsibilities

• 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
• Collaborate with external partners, suppliers, and manufacturing sites
• Contribute to regulatory submissions and audit readiness
• Assist with device investigations for clinical and commercial products

What We’re Looking For

• 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
• Familiarity with standards such as: ISO 13485, ISO 14971, 21 CFR 820 / 21 CFR Part 4
• EU Medical Devices Regulation
• Understanding of Human Factors / Usability Engineering
• Knowledge of GMP and quality systems

Why Apply?

• Work with a world-renowned pharmaceutical organisation
• Gain exposure to cutting-edge device and combination product development
• Collaborative and innovative environment