12m Contract
Cambridge (2.5 days per week average on site)
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
1. Lead and support design control and risk management activities across device and combination product programmes.
2. Prepare and review Design History File (DHF) and risk management documentation.
3. Ensure compliance with quality systems and regulatory standards.
4. Support design validation activities, including human factors / usability engineering.
5. Assist with regulatory submissions, supplier assessments, and quality audits.
6. Support investigations related to clinical and commercial device manufacturing.
Requirements
7. Degree in a relevant science or engineering discipline.
8. Experience in medical devices, combination products, pharma, or biotech.
9. Knowledge of design controls and risk management.
10. Familiarity with ISO, ISO, 21 CFR, 21 CFR Part 4, and EU MDR.
11. 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.