Quality Assurance Manager

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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