1 of 1 Permanent ISO 13485 Jobs in the Midlands

opportunity for a Quality Assurance Manager to join them on a permanent basis. As their new QA Manager, you will be responsible for leading Quality Assurance, ensuring compliance with ISO 13485, FDA 21 CFR Part 820 and other applicable international regulations. This is a key leadership role, managing the QA team, driving a culture of compliance, and ensuring … strategic and operational quality objectives. Key Responsibilities Lead and develop the QA team, managing performance, training, and mentoring. Maintain and continually improve the Quality Management System in compliance with ISO 13485, FDA QSR, EU MDR and other applicable standards. Oversee internal and external audits, including hosting regulatory inspections. Manage CAPA, NCR, and root cause analysis processes, ensuring timely … monitoring. Experience and Skills Required 5+ years of Quality Assurance experience within the Medical Device sector. Minimum of 2 years in a managerial or leadership role. Strong knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820 and EU MDR. Experience hosting regulatory inspections and leading internal audits. Proven leadership skills with the ability to influence More ❯