Director, Post-Market Quality for AI SaMD

Socket.dev; Austin (TX); On-site; USD 180,000 - 225,000; Full time

Job summary

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

Qualifications

• Bachelor's degree or higher in engineering or science.
• 13+ years in quality within medical devices, with leadership experience.
• Expert knowledge of MDR, FDA QMS, ISO 13485, ISO 14971.
• Demonstrated MDR/vigilance reporting ownership and inspections.

Responsibilities

• Lead Complaint Handling, Product Investigations, and Adverse Event Reporting.
• Oversee EU MDR PMS, post-market surveillance, and field actions.
• Develop risk management, CAPA, and signal escalation plans.
• Collaborate with Regulatory, R&D, Clinical, and Product to improve processes.
• Coach and mentor a growing post-market team to a quality-first culture.
• Ensure timely and credible reporting to authorities across regions.

Skills

Post-market

Regulatory

Leadership

Quality Systems

MDR & Vigilance

SaMD AI

Education

Engineering degree

Job description

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