HeartFlow
Senior Manager, Quality System & Compliance
$195K–$250K
San Francisco Bay Area, California, United States +1 · Manager · Full-time · Posted Sep 2, 2026
- Location
- San Francisco Bay Area, California, United States
San Francisco - Experience
- 10+ years in Quality in the medical device industry, including at least 5+ years in a leadership/management role.
- Education
- Bachelor's degree in engineering or a scientific discipline, or equivalent.
About the job
Leads HeartFlow’s Quality Management System and regulatory compliance program for medical devices, including SaMD, audits, continuous improvement, and team development.
What you'll do
- Oversee QMS subsystems and drive continuous improvement to meet global medical-device requirements.
- Lead QMS audit and inspection readiness, serving as a subject matter expert for regulatory authorities.
- Lead and develop the QMS team, promote a quality-first culture, and collaborate across functions on quality processes.
What they ask for
- Bachelor's degree in engineering or a scientific discipline, or equivalent.
- 10+ years of progressive Quality experience in the medical device industry, including at least 5+ years in a leadership/management role.
- Expert-level knowledge of FDA 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971.
- Experience leading or serving as a key SME in regulatory inspections, including FDA or Notified Body inspections.
Nice to have
- Direct experience with AI/ML-driven SaMD and cloud-based medical device platforms.
- Familiarity with medical device cybersecurity standards and data privacy regulations; experience with global regulatory submissions is also preferred.
Pay
USD $195,000 - $250,000 base salary
Tools
FDA 21 CFR 820, ISO 13485, IEC 62304, ISO 14971, AAMI TIR57
AI focus
Preferred experience includes AI/ML-driven SaMD; the role focuses on quality-system oversight and regulatory compliance for medical devices.
Model-written summary · the original posting is authoritative