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.
Head of Quality - 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
Head of Quality - Requirements:
* Extensive leadership experience in Quality roles within medical device or regulated industries, including ISO 13485 and MDR compliance
* Proven track record in managing QMS, audits, CAPA, and inspection readiness (MHRA, Notified Bodies)
* Strong knowledge of regulatory frameworks including UK MDR, EU MDR, and FDA requirements - particularly relevant to medical device technologies
* Excellent cross-functional collaboration, leadership, and stakeholder management skills
* Fluent in English and based in or near Cambridge, UK, with ability to maintain on-site presence as needed
* Passionate about fostering a quality-first mindset in an innovation-driven environment
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us