Sr. Manager - Quality System & Compliance
Posted on October 10, 2025 (about 5 hours ago)
Company Overview
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). The pipeline of products is growing and so is the team; join us in helping to revolutionize precision heartcare.
Job Responsibilities
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 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.
Quality Management System (QMS) Oversight
- Direct all aspects of the QMS to ensure compliance with global regulations, including FDA, ISO 13485, EU MDR, and MDSAP countries’ requirements.
- Oversee key QMS subsystems: CAPA subsystem, Document Control, Training, Management Review, Internal Audits, and External Audit management.
- Drive continuous improvement initiatives to enhance the efficiency and effectiveness of the QMS.
Quality Compliance & Audits
- Serve as the primary subject matter expert for the QMS during audits, including inspections by the FDA, Notified Bodies, and other regulatory authorities.
- Prepare 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, using KPIs to drive accountability and data-driven decisions.
- Collaborate with leaders in R&D, Regulatory, Clinical, and Product Management to integrate quality processes while balancing compliance with business objectives.
- Manage departmental resources including headcount and long-term strategic planning.
Skills Needed
- Effective, clear, and concise communication 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 5+ years in leadership/management roles.
- Expert-level knowledge of regulations including FDA 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971.
- Proven track record in regulatory inspections (FDA, Notified Body).
- Exceptional leadership and communication skills with ability to influence and build consensus among senior leaders.
- Preferred: Experience with AI/ML-driven SaMD, cloud-based medical device platforms, cybersecurity standards, and global regulatory submissions (CE Marking, PMDA).
- Experience implementing and scaling quality processes in fast-paced environments.
Compensation
Estimated salary range for San Francisco Bay Area is $185,000 to $245,000 per year, with cash bonus and equity. #LI-Hybrid
Equal Opportunity Employer Statement
Heartflow is an Equal Opportunity Employer committed to diversity and non-discrimination in employment.
How to Apply
Apply through the Heartflow careers page via the given Greenhouse job link. Submit required documents including resume/CV and cover letter as indicated in the application form.