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.
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 .
Degree in a relevant science or engineering discipline . Experience in medical devices, combination products, pharma, or biotech . Knowledge of design controls and risk management . 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….