Quality Lead in Huddersfield

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.
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