Quality Manager

About the role

The Quality Manager will take full ownership of the ISO 13485 Quality Management System (QMS) and lead quality activity across the business.

Responsibilities

• Maintain, develop, and continuously improve the QMS in line with ISO 13485:2016 and applicable medical device regulations
• Lead non-conformity management, CAPA, change control, document control, and training processes
• Plan and conduct internal, supplier, and Notified Body audits
• Manage supplier qualification, monitoring, and performance reviews
• Support batch release, traceability, complaint handling, and post-market surveillance activities
• Contribute to CE marking maintenance under the MDR, Clinical Evaluation Reports, PSURs, and wider regulatory documentation
• Maintain awareness of regulatory changes and support the company's broader regulatory strategy

Requirements

This is not a corporate quality role. The role comes with a defined pathway for growth, including potential PRRC responsibility as the business continues to develop.

Qualifications

• Proven quality management experience within the medical device industry
• Strong ISO 13485 knowledge, including hands-on QMS development and maintenance
• Experience planning and conducting internal and supplier audits, with exposure to Notified Body audits
• A solid grasp of CAPA management, non-conformance handling, and document control
• A working knowledge of the EU MDR, with FDA QMSR experience a plus
• An interest in regulatory affairs and the ambition to grow into it
• A practical, roll-your-sleeves-up mindset suited to a fast-moving SME

Benefits

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Pay

£50,000 to £60,000

Schedule

Based primarily on-site in Stevenage, Hertfordshire with one day per week working from home