Full job descriptionQuality Control Systems - 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 Systems Co-ordinator 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.