Senior QA Quality Engineer

A well-established global manufacturer of orthopaedic medical devices is looking to appoint a Senior QA Quality Engineer to join its Quality function in the South West of England. The company specialises in the development of implantable technologies designed to enhance patient mobility and long-term outcomes, supplying products to healthcare systems worldwide. 

In this position, you will take on a senior role within Quality Assurance, supporting the effectiveness of the Quality Management System and driving compliance across manufacturing operations. You will partner closely with teams across R&D, Operations, and Validation, ensuring quality is embedded throughout the full product lifecycle while contributing to ongoing improvement initiatives. 

Your responsibilities as the Senior QA Quality Engineer will include: 

• Assessing manufacturing and quality processes to ensure alignment with ISO 13485, GMP, and FDA 21 CFR Part 820 requirements 
• Leading and supporting quality investigations, including NCRs, CAPAs, and root cause analysis activities 
• Driving risk management processes and supporting continuous improvement across the business 
• Contributing to internal audit programmes and delivering GMP and GDocP training where required 
• Managing change control activities and reviewing key quality documentation such as SOPs and specifications 
• Supporting the ongoing development and compliance of the Quality Management System 
• Working collaboratively with cross-functional teams including R&D, Operations, and Validation 
• Monitoring and analysing quality metrics, supporting complaint investigations, and improving KPI performance 

To be successful as the Senior QA Quality Engineer, you will need to demonstrate: 

• Previous experience within a regulated industry such as medical devices or pharmaceuticals 
• Strong knowledge of quality processes including CAPA, NCRs, risk management, and change control 
• An engineering qualification (HNC/HND or degree), ideally in mechanical or biomedical engineering 
• Practical experience within a manufacturing-focused Quality Assurance role 
  Familiarity with GMP and key regulatory standards such as ISO 13485 and FDA 21 CFR Part 820 
• Strong analytical thinking, organisation, and problem-solving capabilities 
  Confidence in working cross-functionally and influencing quality-driven outcomes 

Additional experience that would be beneficial includes: 

• Exposure to orthopaedic or implantable medical devices 
• Involvement in audit readiness and regulatory inspections 
• Experience operating within complex, fast-paced manufacturing environments 
• Strong communication skills with the ability to challenge and enhance existing processes 

Senior QA Quality Engineer | Orthopaedic Devices | Medical Devices | ISO 13485 | GMP | FDA 21 CFR 820 | CAPA | NCR | Risk Management | Quality Systems | Manufacturing Quality