Quality Lead

Quality Control Officer - Medical Devices Hybrid working model plus excellent benefits package Must have relevant industry experience of or exposure to ISO 13485. An established medical device business is looking for a Quality Lead to support the day-to-day operation of its Quality Management System and wider quality activity. Working closely with the Quality Assurance Manager, this is a hands-on role covering QMS coordination, internal audits, CAPA, complaints, non-conformances and regulatory quality support.

Key responsibilities Coordinate the day-to-day operation and continual improvement of the QMS Coordinate the risk-based internal audit programme, including findings and corrective actions Coordinate CAPA, complaints and non-conformances, including root cause and effectiveness reviews Manage document control, quality records and quality metrics Support compliance with ISO 13485 and MDSAP Provide quality evidence and support to Regulatory Affairs Coordinate supplier quality activity and monitor emerging quality risks Support quality training and provide practical guidance to colleagues Experience required Practical experience in a regulated quality environment, ideally medical devices Working knowledge of ISO 13485

Experience of CAPA, assisting in or preparing for internal audits, complaints, non-conformances and document control Strong organisation skills with the ability to manage competing priorities Confident reviewing information, identifying gaps and escalating quality issues Relevant quality qualification, degree or equivalent experience preferred Internal Auditor / Lead Auditor qualification desirable Experience supervising or coaching colleagues desirable The opportunity A broad quality role offering the opportunity to develop further experience across QMS, auditing, CAPA, complaints and regulatory compliance within a medical device environment.