Job Description
We're working with a leading Medical Technology company who are actively recruiting a Quality Engineer to be based in Cambridge.
Please note that you must meet all the criteria set out below for your application to be considered. Suitable candidates will be contacted within 5 working days. If you are not contacted by us within that time, please consider your application unsuccessful on this occasion.
The main responsibilities will include but not limited to:
- Lead high‑impact supplier audits and keep all supplier approvals, certifications, and records tight and up to date.
- Strengthen supplier performance by working hand‑in‑hand with Supply Chain and Operations.
- Champion design quality processes and play a key role in driving design‑related product changes.
- Take ownership of design verification activities — from test method development to validation and final sign‑off.
- Bring strong Design Control expertise to influence and elevate new product development.
- Embed robust verification, validation, and review practices across cross‑functional project teams.
- Play an active role in internal audits and help push forward wider quality initiatives.
- Drive meaningful process improvements and support CAPA/NCR actions that keep quality moving forward.
- Coach teams to produce clear, compliant procedures, protocols, risk assessments, and controlled documents.
- Build problem‑solving capability across the business and ensure quality data is captured accurately.
To be successful, you will need to meet the following:
- Internal Auditor or Lead Auditor training (ISO 13485 preferred).
- Familiarity with IEC 60601‑1 standards (advantageous).
- Working knowledge of ISO 13485, ISO 14971, ISO 19011, QMSR, MDR, and MDSAP.
- Experience within a regulated environment such as medical devices or pharmaceuticals.
- A relevant degree or equivalent industry‑aligned qualifications.
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Hiring? If you need help filling a similar position in your company, please contact us on +44 (0)208 137 0401 or click here.
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