Head of Quality

Divisional Manager - Contract at Mantell Associates

Mantell Associates is partnered with a dynamic Medical Device company based in Cambridge, who is seeking an experienced and visionary Head of Quality to lead quality assurance and regulatory excellence across its innovative product portfolio.

This strategic role will drive quality systems, inspections, and product compliance at one of the UK's most vibrant life sciences hubs.

Responsibilities

• Lead and manage the site-wide Quality Management System (QMS), ensuring robust, compliant systems aligned with ISO 13485, MDR, and MHRA regulations
• Oversee internal audits, supplier / vendor quality assessments, and readiness for regulatory inspections and third-party audits
• Collaborate closely with R&D, Engineering, Manufacturing, Regulatory Affairs, and Supply Chain teams to embed quality principles from product development through post-market activities
• Champion continuous improvement initiatives to enhance product quality, process efficiency, and compliance culture
• Act as the executive quality representative - supporting risk assessments, CAPA programs, change control processes, and quality governance
• Mentor and develop a high-performing quality team, promoting best practices and professional development

Qualifications

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.

Details

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