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← Heartflow

Senior Manager, Quality System & Compliance

Heartflow
Location
San Francisco Bay Area, California, United States
Posted
18 days ago
Department
Quality
Salary
$195,000 - $250,000
What they actually want (must-haves)
  • Bachelor's degree in engineering or scientific discipline, or equivalent
  • 10+ years of progressive experience in Quality within the medical device industry
  • At least 5+ years in a leadership/management role
  • Expert-level knowledge of relevant regulations and standards, including FDA 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971
  • Proven track record of successfully leading or playing a key SME role in regulatory inspections
  • Exceptional leadership and communication skills
Nice to have
  • Direct experience with AI/ML-driven SaMD and cloud-based medical device platforms
  • Familiarity with medical device cybersecurity standards (e.g., AAMI TIR57) and data privacy regulations
  • Experience with global regulatory submissions (e.g., CE Marking, PMDA)
  • Experience implementing and scaling quality processes in a fast-paced and growing environment
What the job really is

As the Senior Manager of Quality System and Compliance at Heartflow, you will lead the strategy and execution of the Quality Management System (QMS) to ensure compliance with medical device regulations. This role involves managing various QMS subsystems, preparing for audits, and fostering a quality-first culture within the organization. You will also mentor a team of quality professionals and collaborate with cross-functional leaders to integrate quality processes with business objectives.

Benefits
  • Estimated base salary of $195,000 - $250,000
  • Bonus
  • Equity
Things to weigh
  • Role requires deep expertise in QMS setup and management, particularly for Software as a Medical Device (SaMD)
  • Position involves navigating complex regulatory landscapes
  • No specific mention of remote work flexibility beyond hybrid model
Job score4/5
Benefits2/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency5/5

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