Mgr, Quality Systems Operations

The Quality Systems Operations Manager leads the effective operation, governance, and continuous improvement of Quality Management System processes, with a primary focus on CAPA, nonconformance management, audit compliance, and risk-based quality practices. This role involves overseeing the Quality Systems team, ensuring regulatory compliance with standards such as ISO 13485 and FDA QMSR, and driving cross-functional collaboration to maintain scalable and compliant quality operations. The position requires strong leadership in quality metrics, root cause analysis, and continuous improvement initiatives within a regulated medical device environment.