The Role We are seeking an experienced and proactive Quality Manager to lead our quality assurance and control activities and maintain our Quality Management System (QMS) in accordance with ISO 13485 and 21 CFR 820. This is a pivotal leadership role within our growing medical device business ensuring ongoing compliance, managing a team of Quality Technicians, and fostering a strong culture of quality across all departments. The Quality Manager will act as the management representative for our ISO 13485:2016 QMS and will liaise with client quality teams to ensure alignment and effective communication on quality standards and regulatory expectations. Key Responsibilities: Maintain and ensure compliance with the QMS with ISO 13485 and 21 CFR 820 Lead internal and external audits, management reviews, supplier qualification, and CAPA processes. Oversee document control, change control, training systems, and non-conformance investigations. Act as Management Representative for ISO 13485:2016 compliance and continuous improvement. Implement and monitor quality control systems. Conduct and oversee product batch reviews and be responsible for release of product. Oversee and ensure timely and accurate quality control testing and related reporting. Manage a team of Quality Technicians, ensuring appropriate training and development, to deliver QA/QC needs in a timely manner. Build and promote a quality-driven culture across the organisation. Participating as a member of the management ..... full job details .....