Program Manager, Quality, AIS

This role provides quality oversight for AI and machine learning-enabled medical devices, including Software as a Medical Device (SaMD), supporting the full product lifecycle from design through post-market activities. The position ensures patient safety, product quality, and regulatory compliance by applying design controls, risk management, and quality-system requirements across engineering, clinical, and program teams. It also involves supporting investigations, CAPAs, audit remediation, and continuous improvement while resolving complex quality issues.