Senior Quality Engineer

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 Engineer to own and continually improve their Quality Management System (QMS), based in West Yorkshire.

These are QMS-focused roles at the heart of the business's compliance framework. Working closely with Operations, Manufacturing, Supply Chain and Regulatory teams, the successful candidates will be a process owner for core QMS activities — including document control, change control, deviation management, non-conformances and CAPA — ensuring the business remains compliant with ISO 13485, EU MDR 2017/745 and FDA 21 CFR Part 820.

Your Responsibilities as Senior Quality Engineer

• Own, maintain and continually improve Quality Management System (QMS) processes, procedures and documentation across the business.
• Ensure ongoing compliance with ISO 13485, EU MDR 2017/745 and FDA 21 CFR Part 820 requirements.
• Ensure effective document control and change control, keeping QMS records accurate, current and audit-ready.
• Act as the Quality subject matter expert during internal and external audits, and support and help deliver the internal audit programme.
• Investigate non-conformances, deviations and customer complaints, and lead and support CAPA investigations through the QMS to closure.
• Support management review activities by preparing quality metrics, trend analysis and technical reports.
• Conduct supplier qualification and surveillance audits, and develop supplier audit plans, assessment criteria and quality agreements aligned to the QMS.
• Support validation, equipment qualification and risk management activities across the business.
• Identify and drive continuous improvement opportunities within the QMS, supporting a culture of quality and compliance.
• Work collaboratively with cross-functional teams to ensure consistent regulatory compliance and operational excellence across the QMS.

Your Background as Senior Quality Engineer

• Bachelor's degree in Engineering or a relevant scientific discipline, with a minimum of five years' experience within Quality Engineering in the medical device, pharmaceutical or life sciences sector.
• Strong hands-on experience owning or administering a Quality Management System (QMS).
• Strong knowledge of ISO 13485, EU MDR 2017/745 and FDA 21 CFR Part 820.
• Experience conducting supplier audits and supplier quality management, with proven experience managing non-conformances, root cause investigations, CAPA, risk management and process validation within a QMS framework.
• Experience using ERP and Quality Management Systems (QMS) software.
• ISO 13485 Lead Auditor qualification (BSI or equivalent) and FDA QSR / 21 CFR Part 820 audit training.
• Excellent analytical, problem-solving and communication skills, with the ability to influence and build effective working relationships across departments.
• Desirable: EU MDR training or qualification, and Lean/Six Sigma knowledge.

Senior Quality Engineer | QMS | Quality Management System | Quality Engineering | Medical Devices | ISO 13485 | EU MDR 2017/745 | FDA 21 CFR Part 820 | Supplier Quality | CAPA | Root Cause Analysis | Non-Conformance | Document Control | Change Control | Risk Management | Process Validation | Internal Audit | Quality Assurance

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