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Quality Engineer – Compliance (Medical Devices / Combination Products) 📍 Cambridge area, UK (Hybrid – 2.5 days onsite per week) 📅 12-month contract | ⏱ 37 hours per week We are looking for a Quality Engineer – Compliance to support medical device and combination product development programmes within a leading pharmaceutical R&D environment. Key Responsibilities • Lead and support design control and risk management activities across device and combination product programmes., • Prepare and review Design History File (DHF) and risk management documentation., • Ensure compliance with quality systems and regulatory standards., • Support design validation activities, including human factors / usability engineering., • Assist with regulatory submissions, supplier assessments, and quality audits., • Support investigations related to clinical and commercial device manufacturing. Requirements • Degree in a relevant science or engineering discipline., • Experience in medical devices, combination products, pharma, or biotech., • Knowledge of design controls and risk management., • Familiarity with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR Part 4, and EU MDR., • Understanding of GMP and device development processes is beneficial., • If you have experience working in regulated device or combination product environments and are interested in a hybrid contract role in the Cambridge area, please apply or get in touch. If interested, please apply directly or reach out to