---
title: 'Senior Manager, Quality System & Compliance at Heartflow'
canonical: 'https://feeny.ai/job/senior-manager-quality-system-compliance-heartflow-san-francisco-bay-area-fqednnvnrkdv'
type: 'job'
last_seen: '2026-09-14'
---

# Senior Manager, Quality System & Compliance at Heartflow

- **Company:** Heartflow
- **Location:** San Francisco Bay Area California, United States
- **Posted:** 2026-09-03
- **Last confirmed live:** 2026-09-14
- **Apply:** https://job-boards.greenhouse.io/heartflowinc/jobs/6179682004

## Job description

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis—provides a color-coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.

Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 750,000 patients worldwide.

As the Senior Manager of Quality System and Quality (Regulatory) Compliance, you are a pivotal leader responsible for the strategy, execution, and continuous improvement of our Quality Management System (QMS), oversight, and associated tools. You will lead our efforts to ensure robust compliance with national and international medical device regulations, including FDA, ISO 13485, EU MDR, and MDSAP. This role is a unique blend of strategic foresight and tactical leadership, requiring a deep expertise in QMS setup and management, particularly for Software as a Medical Device (SaMD), with ability to make thoughtful changes and enhance the overall QMS.

You will lead a high-performing team of quality professionals , championing a "Quality-first" culture and driving data-driven decisions. Your proven track record of navigating complex regulatory landscapes, including FDA, PMDA, IEC, EU MDR, and ISO regulations and standards, is essential to our success.

Job Responsibilities:

Quality Management System (QMS) Oversight

- Manage holistic aspects of the QMS to ensure compliance with global regulations, including FDA, ISO 13485, EU MDR, and MDSAP countries’ requirements.
- Oversee the following key QMS subsystems: CAPA subsystem, Document Control, Training, Management Review, Internal Audits, and External Audit management, QMS Tool Validation, and Supplier Management.
- Drive continuous improvement initiatives to enhance the efficiency and effectiveness of the QMS.

Quality Compliance & Audits

- Serve as the front room or backroom lead and the primary subject matter expert (SME) for the QMS during audits, including inspections by the FDA, Notified Bodies, and other regulatory authorities.
- Prepare the organization for an appropriate level of quality compliance to U.S. and international requirements to support Heartflow’s global expansion.

Strategic Leadership & Team Development

- Lead, mentor, and scale a team of QMS professionals, fostering career growth and technical excellence.
- Champion a "Quality-first" mindset throughout the organization, through collaboration and using impactful KPIs to drive accountability and data-driven decisions.
- Collaborate with leaders and partners in R&D, Production, Regulatory, Clinical, and Product Management to integrate quality processes seamlessly, balancing compliance with business objectives.
- Manage departmental resources, including headcount and long-term strategic planning.

Skills Needed:

- Effective, clear, and concise communication skills bringing clarity to complex topics across the leadership spectrum.
- Ability to coach, mentor, and drive a collaborative quality culture through influence.
- Deep understanding of Quality System and Quality Compliance.
- Experience interacting with auditors, including Notified Body auditors and FDA Investigators.

Educational Requirements & Work Experience:

- Bachelor's degree in engineering or scientific discipline, or equivalent.
- 10+ years of progressive experience in Quality within the medical device industry, with 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 (FDA, Notified Body).
- Exceptional leadership and communication skills, with a demonstrated ability to influence and build consensus among cross-functional senior leaders.

Preferred:

- 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.

This position has an estimated base salary of $195,000 - $250,000, bonus, and equity. #LI-IB1; LI-Hybrid Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.

Positions posted for Heartflow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.

Heartflow has become aware of a fraud where unknown entities are posing as Heartflow recruiters in an attempt to obtain personal information from individuals as part of our application or job offer process. Before providing any personal information to outside parties, please verify the following: A) all legitimate Heartflow recruiter email addresses end with “@heartflow.com” and B) the position described is found on our careers site at [www.heartflow.com/about/careers/](https://www.heartflow.com/about/careers/).

## About Heartflow

## Company Overview
- **One-liner**: Heartflow is a medical technology company that leverages AI to create personalized 3D models of the heart from a single CT scan, enabling clinicians to diagnose, treat, and manage coronary artery disease (CAD) non-invasively.
- **Entity Type**: Public (NASDAQ: HTFL) – IPO in 2025
- **Headquarters**: San Francisco, California, USA
- **Founded**: 2007
- **Founders**: Not publicly listed on primary company pages; the company was founded by a team including Dr. Charles Taylor (inventor of the core technology). *Note: Founders not explicitly named on the main website.*

## Core Business
- **Primary Industry**: Medical Technology / HealthTech / AI-Driven Diagnostics (Cardiology)
- **Target Customers**: B2B – Hospitals, health systems, and cardiology clinics; the end-users are clinicians (cardiologists, radiologists) and the ultimate beneficiaries are patients with suspected or known CAD.
- **Mission/Purpose**: To transform coronary artery disease (CAD) from the leading cause of death into a disease that can be managed for life.

## Products & Services
- **Heartflow One Platform**: The company’s core AI-driven, non-invasive precision coronary care platform. It provides a suite of analyses from a single Coronary CTA (CCTA) scan:
    - **Roadmap™ Analysis**: Visualizes the coronary anatomy and assesses blood flow anywhere in the coronary tree.
    - **FFRct Analysis**: Computes Fractional Flow Reserve from CT, determining the functional significance of a blockage (the original, most established product).
    - **Plaque Analysis**: Quantifies and characterizes plaque to inform risk stratification and disease management.
    - **Type**: SaaS/Software-as-a-Medical-Device (SaMD) integrated into clinical workflow.

## Market Standing
- **Valuation/Market Cap**: Not publicly available from the provided sources. As a recently public company (2025), market cap fluctuates. *Source: LinkedIn indicates a 2025 IPO.*
- **Key Metric**: Over **650,000 patients treated**; over **1,800 institutions** using the platform; **99.5% of U.S. lives covered** for FFRct Analysis.
- **Notable Investors/Partners**: Not listed in the provided search results. The company is now public.
- **Growth Signals**:
    - Supported by scientific statements from the American College of Cardiology (ACC) and American Heart Association (AHA) for personalized CAD management.
    - Late-breaking data at AHA 2025 reinforced the prognostic power of its Plaque Analysis.
    - Growing evidence base across the CAD care continuum, from risk stratification to CT-guided intervention planning.
    - Backed by **>625 peer-reviewed publications**.
    - LinkedIn follower growth: +32% year-over-year, indicating strong brand and market interest.

## Competitive Advantages
- **First-Mover & Gold Standard in FFRct**: Heartflow created the FFRct technology category and has the most robust clinical evidence base (over 625 peer-reviewed publications) and guideline support (ACC/AHA).
- **Integrated Platform (Heartflow One)**: It is the only complete, non-invasive, precision coronary care platform that covers the entire guideline-directed CCTA pathway (anatomy, physiology, and plaque).
- **Massive Clinical & Reimbursement Moat**: Achieving 99.5% U.S. lives covered creates an enormous barrier to entry for competitors, as reimbursement and clinical adoption are already deeply established.
- **AI-First, Non-Invasive Solution**: Replaces invasive diagnostic procedures (cardiac catheterization) with a safer, cheaper, and more comfortable CT scan, aligning with the industry shift toward value-based care.

## Strategic Focus
- **Deepening the Evidence Base**: Continuing to publish clinical data to expand the use cases for its platform (e.g., from diagnosis to guiding interventions).
- **Global Expansion**: Operating in the US, Europe, and Japan, with a focus on expanding access and adoption in these key markets.
- **Platformization**: Moving from a single product (FFRct) to a comprehensive CAD management platform (Heartflow One) that manages patients from screening through treatment.
- **Lifecycle Management**: Shifting the narrative from a one-time diagnostic test to a tool for managing CAD for the patient's entire life.

## Why Work Here
- **Mission-Driven**: The work directly impacts the world's leading cause of death. The company culture emphasizes a "patient-first" mentality.
- **Remote-First Culture**: The company is remote-first with employees across the US, Europe, and Japan. Hubs include San Francisco (HQ), Austin, London, and Tokyo.
- **Strong Benefits**: Medical/Dental/Vision (90% of premium paid by company), 401k match, parental leave, flexible PTO, and an Employee Assistance Program (EAP).
- **Engineering & Clinical Excellence**: A high-caliber team of engineers, data scientists, and clinicians working on cutting-edge AI in a regulated medical environment. The tech stack involves complex 3D modeling, AI/ML, and cloud infrastructure.
- **Growth Stage**: As a recently public company with strong adoption, it offers a balance of startup energy and established market stability. High growth potential in a mission-critical field.

## Sources
1. [heartflow.com (Company Overview)](https://www.heartflow.com/)
2. [heartflow.com (About Us)](https://www.heartflow.com/about/)
3. [heartflow.com (Careers Page)](https://www.heartflow.com/about/careers/)
4. [Greenhouse (Job Board)](http://job-boards.greenhouse.io/heartflowinc)
5. [LinkedIn (Company Profile)](https://www.linkedin.com/company/heartflow-inc)

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