Atrium
Linkedin · Posted 11d ago
Quality Engineer
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Indexed description
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
- 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
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