Senior Quality Engineer: QMS Lead for Medical Devices

Walker Cole International Ltd; Leeds; On-site; GBP 55,000 - 85,000; Full time

Job summary

Walker Cole International is supporting a well-established medical device manufacturer in their search for two experienced Senior Quality Engineers to own and continually improve their Quality Management System (QMS) based in West Yorkshire.

The successful candidates will drive QMS processes across document control, change control, deviation management, non-conformances and CAPA, ensuring compliance with ISO 13485, EU MDR 2017/745 and FDA 21 CFR Part 820, while collaborating with Operations,

Qualifications

• Bachelor's degree in Engineering or relevant science with 5+ years in quality engineering in medical devices.
• Proven experience owning or administering a QMS.
• Strong knowledge of ISO 13485, EU MDR 2017/745 and FDA 21 CFR Part 820.
• Experience with supplier audits, CAPA, risk management and process validation.
• Experience using ERP and QMS software.

Responsibilities

• Own, maintain and continually improve the QMS processes across the business.
• Ensure ongoing compliance with ISO 13485, EU MDR 2017/745 and FDA 21 CFR Part 820.
• Ensure effective document control and change control, keeping QMS records accurate and audit-ready.
• Act asQuality SME during internal and external audits and support the internal audit programme.
• Investigate non-conformances, deviations and customer complaints, and lead CAPA investigations to closure.
• Support management review activities with quality metrics, trend analysis and technical reports.
• Conduct supplier qualification and surveillance audits and develop supplier audit plans and quality agreements.
• Support validation, equipment qualification and risk management activities across the business.
• Identify and drive continuous improvements within the QMS and promote a culture of quality.
• Collaborate with cross-functional teams to ensure regulatory compliance and operational excellence.

Skills

QMS ownership

Audit management

CAPA investigations

Root cause analysis

Document control

Change control

Regulatory knowledge

Education

Bachelor's degree in Engineering or related field

Tools

ERP systems

QMS software

Job description

Walker Cole International is supporting a well-established medical device manufacturer in their search for two experienced Senior Quality Engineers to own and continually improve their Quality Management System (QMS) based in West Yorkshire.

The successful candidates will drive QMS processes across document control, change control, deviation management, non-conformances and CAPA, ensuring compliance with ISO 13485, EU MDR 2017/745 and FDA 21 CFR Part 820, while collaborating with Operations,