Director, Post-Market Quality & Compliance

Heartflow; Austin (TX); On-site; USD 170,000 - 210,000; Full time

Benefits offered by this job

Cash bonus

Equity

Job summary

Heartflow seeks a senior leader to own post-market quality activities, overseeing complaint handling, product investigations, and adverse event reporting. You will drive CAPA, regulatory submissions, and PMS, ensuring FDA/EU MDR compliance while guiding a growing team.

You will partner with R&D, Clinical, and Regulatory Affairs to embed a quality-first culture and advance AI-enabled device oversight across markets.

Qualifications

• Bachelor's degree in engineering or scientific discipline, or equivalent.
• 13+ years in quality in medical devices with 7+ years in leadership/management.
• Expert knowledge of 21 CFR Part 803/806, FDA QMS, EU MDR, ISO 13485, ISO 14971.
• Experience making MDR and vigilance reporting decisions.
• Proven track record with FDA inspections and Notified Bodies.

Responsibilities

• Direct complaint handling to meet ISO 13485 and FDA QMS requirements.
• Own complaint handling processes, closure rationale, and reportability decisions.
• Approve closure of high-severity files and ensure proper coding.
• Manage complaint cycle time and escalate as needed.
• Ensure accurate customer-facing investigation responses.
• Use AI tools to improve quality processes and monitor SaMD performance.
• Lead Product Investigations with root cause analysis and CAPA routing.
• Coordinate post-market activities including adverse event and PMS reporting.
• Oversee post-market surveillance and real-world device performance.
• Lead recruitment, mentoring, and development of the quality team.

Skills

Quality leadership

Regulatory judgment

Integrity and ethics

Coaching and mentoring

Complaint handling knowledge

Auditor interaction

AI/ML SaMD understanding

Education

Bachelor's degree in engineering or scientific discipline

Tools

AI/ML-driven SaMD experience

Job description

Heartflow seeks a senior leader to own post-market quality activities, overseeing complaint handling, product investigations, and adverse event reporting. You will drive CAPA, regulatory submissions, and PMS, ensuring FDA/EU MDR compliance while guiding a growing team.

You will partner with R&D, Clinical, and Regulatory Affairs to embed a quality-first culture and advance AI-enabled device oversight across markets.