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 compliance.
To be successful as the Quality Engineering Manager, you will need:
* A Bachelor of Science degree or equivalent in a technical discipline (e.g., Engineering).
* Leadership experience in a medical device environment compliant with ISO 13485, MDR 2017/745, and 21CFR820.
* Strong background in Quality Engineering, Quality Control, CAPA, non-conformance resolution, and validation.
* Solid knowledge of ISO 14971, Lean, Six Sigma, and quality improvement tools.
* Excellent communication, problem-solving, and team-leadership skills.
* Experience with statistical tools such as Minitab is beneficial.
Quality Engineering Manager| Quality Engineering | ISO 13485 | MDR 2017/745 | 21CFR820 | Medical Devices | CAPA | SCAR | Process Validation | PFMEA | DFMEA | ISO 14971 | Quality Systems | Leeds Quality Jobs