Quality Manager – Berkshire – Medical Device
About the Company
We are looking for an experienced Medical Device Quality Manager to oversee the quality department and team at a specialist medical device company in Berkshire.
Responsibilities
* Own, maintain, and continuously improve the ISO 13485 Quality Management System.
* Lead and manage external audits, including customer, notified body, and regulatory inspections.
* Plan and conduct internal audits, ensuring ongoing compliance and audit readiness.
* Support new product introduction (NPI), validation activities, and process changes from a quality perspective.
* Manage supplier quality activities, including supplier approval, performance monitoring, and corrective action.
* Drive continuous improvement initiatives and promote a strong quality culture throughout the business.
* Lead, mentor, and develop members of the quality team.
Requirements
* Substantial quality management experience from the medical device manufacturing industry.
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