Director, Post-Market Quality for AI SaMD

Heartflow in the San Francisco Bay Area is seeking a Director of Post-Market Quality to lead complaint handling, product investigations, and adverse event reporting in compliance with FDA MDR, EU MDR, and ISO standards for SaMD. This executive role guides a cross-functional team across quality systems and post-market activities.

You will drive data-driven risk management, CAPA, and field actions while partnering with Regulatory Affairs, Clinical, R&D, and Product Management to ensure patient