Medical Devices Quality Assurance Specialist

Medical Devices Quality Assurance Specialist: At GAMA Healthcare, we’re looking for an experienced Medical Devices Quality Assurance Specialist, with sound knowledge of ISO 13485, to join our growing RA & QA team. You will handle all aspects of quality management within the scope of the company’s certified and mandatory quality management systems (QMS). Here at GAMA, we’re at the forefront of infection prevention technology and products. We span several regulatory frameworks which makes our RA & QA function varied, challenging and an exciting opportunity for an enthusiastic quality professional to develop your career. What will you do? Contributing to cross-functional team projects, providing advice on QA matters Maintenance and development of the Quality Management System Handling controlled documents and specifications Analysis of post market surveillance (PMS) and vigilance activities for medical devices Operation of the supplier qualification process Supporting the company’s quality audit programmes Handling customer complaints (investigation; documentation; communication) Handling the Corrective and Preventative Action Process What will you need? Previous success within a Quality Assurance role, with knowledge of ISO 13485 - this is essential A sound knowledge of either a science, microbiology or infection control, gained either through academic programmes or experience Good organisation & planning skills Experience of managing investigations and/or auditing exercises Strong technical writing and data analysis skills An appetite to work in a fast-paced environment as part of a professional Global Regulatory and Quality Assurance team What will you get? A competitive salary between £28,000 – 35,000 Annual performance bonus 25 days holiday (plus statutory) A competitive, contributory pension scheme Private Medical Insurance & Health Cashback plan Cycle to work & discounted gym memberships What’s it like at GAMA? At GAMA Healthcare we’re motivated by purpose, not just the potential of our brands. We’re an innovative company led by two inspiring entrepreneurs. The pace is fast and, when needed, we can shift direction quickly, but we pull together to get things done. We’re proud of our people and you’ll always have the support and encouragement needed to be successful. For several years we’ve achieved double digit growth and we’re not stopping there. We’re looking for capable people to join us on our journey. Apply now. GAMA Healthcare Ltd are working in partnership with MaxAd Recruitment to source candidates.