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
- 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.