Quality Engineering Manager

Job Description

A leading medical device company in Leeds is seeking a Quality Engineering Manager to oversee key quality functions within a highly regulated ISO 13485 environment. This role is central to ensuring product compliance, driving operational excellence, and supporting the delivery of high-performance medical devices used worldwide.

As the Quality Engineering Manager, you will work closely with Operations, R&D, Regulatory Affairs, and Engineering to maintain a robust QMS, lead improvement initiatives, and strengthen quality performance across the site.

Your responsibilities as the Quality Engineering Manager will include :

• Leading and developing the Quality Engineering and Quality Control teams.
• Managing non-conformance investigations, CAPA, SCARs, and root cause analysis aligned with ISO 13485, MDR 2017 / 745, and 21CFR820.
• Ensuring inspection, testing, calibration, and labelling processes meet QMS requirements.
• Supporting PFMEA, DFMEA, process validation (IQ / OQ / PQ), and ISO 14971 risk management.
• Driving continuous improvement across quality systems and manufacturing processes.
• Monitoring quality metrics and creating reports to support operational decisions.
• Supporting internal / external audits and maintaining regulatory readiness.

Leading quality improvement projects to enhance efficiency and c…