Description
The Quality Manager will own SoftWave TRT’s Quality Management System and compliance infrastructure for medical devices, including QMS governance, CAPA administration, supplier quality oversight, audit leadership, regulatory support, change control, and quality records. The role requires a bachelor’s degree or equivalent relevant experience, at least 7 years of progressive quality experience in a regulated manufacturing environment, and experience with FDA and ISO 13485 compliance activities. The position works cross-functionally with Operations, Engineering, Regulatory Affairs, Supply Chain, and Service teams.
