Senior Manager, Quality System & Compliance
Heartflow· Quality
Hybrid (San Francisco Bay Area)Full-timePosted 1mo ago
About the role
Senior leader responsible for strategy, execution, and continuous improvement of Heartflow's Quality Management System (QMS) and compliance with global medical device regulations (FDA, ISO 13485, EU MDR, MDSAP) with focus on SaMD and cloud-based platforms.
Responsibilities
- Manage holistic aspects of the QMS to ensure compliance with global regulations, including FDA, ISO 13485, EU MDR, and MDSAP countries’ requirements.
Skills
Required:Quality Management System (QMS)Regulatory inspections & audits
Benefits
- Base salary: $195,000 - $250,000
- Bonus
- Equity
Last updated Sep 14, 2026. Interested? Apply on the company site.
About Heartflow
Decisive Coronary Care
Heartflow’s vision is to transform CAD from the leading cause of death into a disease that can be managed for life.
CCTA ResourcesRoadmap AnalysisFFRCT AnalysisPlaque AnalysisHeartflow OneHeartflow One PlatformMeasurable Impact
More open roles at Heartflow
- Territory Account Manager - Seattle, WA; Bellevue, WA; Everett, WAtodayRemote · US Sales
- Territory Account Manager - North Chicago, ILtodayNorth Chicago, IL · US Sales
- Territory Account Manager - North Denver, COtodayHybrid (Denver, CO) · US Sales
- Territory Account Manager - Atlantic City, NJtodayRemote · US Sales
- IT Director, Infrastructure and OperationstodayHybrid (Rohnert Park, CA) · Corp IT