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
* 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
* 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
#J-18808-Ljbffr