Lead Specialist, Quality Management Systems

This role leads the establishment, maintenance, and continuous improvement of a Quality Management System (QMS) compliant with ISO 13485 and Japanese regulations for medical devices. The incumbent collaborates with departments to manage quality documentation, conduct internal audits, oversee non-conformance processes, and respond to audits from regulatory authorities and third-party agencies. Key duties include driving corrective and preventive actions (CAPA), managing supplier evaluations, and reporting quality metrics to executive leadership.