Quality Systems Specialist

This role manages the end-to-end lifecycle of corrective and preventive actions, nonconformance reports, and change events within a regulated medical device or Software as a Medical Device environment. The specialist ensures compliance with ISO 13485, FDA 21 CFR Part 820, and MDSAP requirements while supporting software release processes and quality audits. The position involves maintaining quality management systems, overseeing documentation control, and coordinating cross-functional efforts to drive quality and regulatory adherence.