Senior Quality Manager – Medical Devices About the Role Skills Alliance is proud to partner with leading organisations in the medical device sector. We are currently seeking a Senior Quality Manager with 5+ years of experience to lead and support quality assurance activities, ensuring compliance with global quality standards and regulatory requirements. Responsibilities Lead and manage the implementation and maintenance of the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, MDR, and other relevant standards. Oversee internal and external quality audits, including supplier and notified body audits. Drive continuous improvement initiatives related to quality processes and compliance. Manage CAPA, non-conformances, risk management, and change control activities. Collaborate closely with R&D, Manufacturing, and Regulatory teams to ensure quality standards are met throughout product lifecycle. Provide leadership and training to quality teams and cross-functional departments on quality systems and compliance. Monitor and report on key quality metrics to senior management. Requirements Degree in Life Sciences, Engineering, or related field. 5+ years of experience in quality assurance within the medical device industry. Strong knowledge of ISO 13485, FDA QSR, MDR, and risk management (ISO 14971). Proven experience leading quality teams and managing quality systems in regulated environments. If you’d like to explore exciting opportunities in medical devices, apply now or connect with me directly for a confidential conversation. Details Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: Medical Equipment Manufacturing #J-18808-Ljbffr