Quality Manager

We're supporting an established medical device manufacturer looking to engage a Senior Quality Manager on a contract basis, with a strong focus on on-site leadership.

This role will suit a hands-on QA professional who is comfortable balancing both strategic oversight and operational delivery within a regulated, high-volume manufacturing environment. You'll play a critical role in driving quality culture, ensuring compliance, and acting as a key decision-maker across site operations.

Key Responsibilities:

• Lead all site Quality activities, ensuring compliance with ISO 13485, GMP, and applicable regulatory standards
• Own and continuously improve the Quality Management System (QMS), ensuring it remains audit-ready at all times
• Act as the primary Quality representative on site, working cross-functionally with manufacturing, engineering, supply chain, and leadership teams
• Drive audit readiness and lead external audits/inspections, including notified body and regulatory interactions
• Oversee CAPA, deviations, non-conformances, and root cause investigations, ensuring timely and effective closure
• Champion continuous improvement initiatives and strengthen quality culture across the site
• Provide guidance and mentorship to QA teams, fostering a high-performance environment

Requirements:

• Strong background in Quality within the medical device sector (or closely related regulated industry)
• Proven experience operating in a senior, site-based QA leadership role
• In-depth knowledge of ISO 13485 and manufacturing/GMP environments
• Demonstrated experience managing audits and regulatory inspections
• Comfortable operating in fast-paced, complex manufacturing settings
• Pragmatic, solutions-driven mindset with excellent stakeholder engagement and influencing skills

If this could be of interest, or you know someone suitable, feel free to reach out directly.