Quality Engineering Manager

Walker Cole International; West Yorkshire; On-site; GBP 100,000 - 125,000; Full time

Job summary

A leading medical device company is seeking a Quality Engineering Manager to oversee quality functions in compliance with ISO 13485 standards. This role involves leading the Quality Engineering and Quality Control teams, managing compliance investigations, and driving continuous improvement initiatives. The ideal candidate should have experience in a similar role and a strong understanding of regulatory requirements. This position is key to ensuring the delivery of high-performance medical devices used globally.

Qualifications

• Experience in a management role within a quality function of a medical device or closely regulated industry.
• Strong understanding of ISO 13485 and related regulatory frameworks.
• Proven track record in leading quality improvement initiatives.

Responsibilities

• Lead and develop the Quality Engineering and Quality Control teams.
• Manage non-conformance investigations and CAPA aligned with ISO and MDR.
• Ensure compliance of inspection and validation processes with QMS requirements.
• Drive continuous improvement across quality systems.

Skills

Leadership

Quality Management Systems (QMS)

Regulatory Compliance

Root Cause Analysis

Continuous Improvement

Job description

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...