Quality Engineer

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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