Quality Assurance Manager

About the role

The Quality Assurance Manager will lead quality performance, compliance and continuous improvement within a highly regulated manufacturing environment. Reporting to senior leadership, you will ensure products meet the highest standards, maintain certifications and embed a strong quality culture across the business.

Key responsibilities

• Develop, implement and maintain robust quality assurance processes.
• Lead complaint investigations, internal audits, CAPA and change management activities.
• Maintain ISO 13485 certification and support FDA Quality System compliance.
• Reduce cost of poor quality and drive customer satisfaction.
• Manage and mentor the Quality Officer, Quality Specialist and Validation Engineer.
• Coordinate training and collaborate with the training & development team.
• Work cross‑functionally with Continuous Improvement, Supply Chain and Manufacturing.
• Make independent decisions using sound judgement and manage the quality budget.

Required profile

• Bachelor’s degree in natural science, engineering, medical technology or equivalent.
• Minimum 5 years’ QA experience in a regulated manufacturing environment.
• Strong knowledge of ISO 13485:2016 and FDA Quality System requirements.
• Proven experience with complaint investigation and resolution.
• High attention to detail and passion for quality and continuous improvement.

Required skills

• ISO 13485
• FDA Quality System (QSR)
• 8D problem‑solving methodology
• CAPA management
• 5 WHY analysis
• PDCA cycle
• 5S workplace organisation

What we offer

• £56,000 per annum
• Full‑time, Monday‑Friday schedule
• On‑site role based in Gloucester within a regulated manufacturing environment