JOB – Quality Manager (Medical Devices)
LOCATION – Stevenage
TERM – Permanent
SALARY – £55,000 to £75,000 per annum (plus benefits)
My client is a leading medical device manufacturer supplying innovative products to the healthcare sector. They are looking to take on a
Quality Manager
to oversee and drive the Quality Management System in line with
ISO 13485
standards, based at their site in Stevenage.
The Quality Manager will ideally have the following attributes:
• Proven experience in a
Quality Management role
within the
medical device industry
• Strong knowledge and hands-on experience with
ISO 13485
and regulatory compliance (FDA, MDR)
• Experience leading external and internal audits, maintaining certifications, and managing notified body interactions
• Excellent understanding of CAPA, risk management, design assurance, and validation
• Ability to mentor, develop, and manage a quality team
• Strong communication, leadership, and influencing skills
• Proficiency in Microsoft Office and quality management tools
The Quality Manager role will involve:
• Leading the Quality Department to ensure compliance with
ISO 13485
and regulatory requirements
• Developing and maintaining the company's QMS to meet customer, regulatory, and business needs
• Managing audits, inspections, and certification processes
• Driving continuous improvement across quality processes and product lifecycle management
• Ensuring product compliance from design through to manufacture and post-market surveillance
• Working closely with R&D, production, supply chain, and regulatory affairs teams
• Reporting quality metrics and compliance status to senior leadership
If you are interested in this position, please apply with an up-to-date CV as soon as possible, along with your availability and salary expectations.