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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