More jobs:
Quality Engineer
Job in
Cambridge, Cambridgeshire, CB21, England, UK
Listed on 2026-10-16
Listing for:
Cpl Life Sciences
Full Time
position Listed on 2026-10-16
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Medical Device Industry, Regulatory Compliance Specialist
Job Description & How to Apply Below
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
.
- 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
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