Kinetic is working with a leading Medical Technology company that is actively recruiting a Quality Engineer to be based in Cambridge.
Key aspects of the role include:
* 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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