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Heartflow

Senior Manager, Quality System & Compliance

Heartflow · San Francisco Bay Area, California, United States

Posted 14 days ago · $195,000 - $250,000

or apply directly on Heartflow's site. We never take the application ourselves.

Is this posting real?

This role has been open
14 days
Heartflow's roles stay open a median of 35 days
Reposted
No
Salary listed
Yes
65% of Heartflow's roles list one
Ghost-job risk at Heartflow
moderate
19 stale, 1 reposted of 63 open
Hiring momentum
120 roles opened in the last 90 days
↑ up vs. the prior 90 days
Last confirmed on the employer's board
2026-09-17

Measured from postings appearing on and disappearing from Heartflow's own greenhouse board since 2026-08-03. Full hiring picture for Heartflow.

About this role

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.

Our read on this posting4.0out of 5
benefits
2/5
freshness
4/5
career value
4/5
role clarity
5/5
pay transparency
5/5

Scored from the posting itself — how clearly the role is described, how much it says about pay and benefits, and how recently it was listed. Not a judgement of Heartflow as an employer.

What you need

  • 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 you get

  • Estimated base salary of $195,000 - $250,000
  • Bonus
  • Equity

Worth weighing

  • 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

Summarised from Heartflow's posting. Read the full original.

Listed by Heartflow on their greenhouse job board, last confirmed open on 2026-09-17. PitchMeAI is not the employer.

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