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Director, Quality

San Francisco Bay Area, California

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 400,000 patients worldwide.  

Hearflow is seeking a seasoned and strategic Director of Quality to lead our Quality Management System (QMS) and Software Design Quality teams.  This critical and highly visible leadership role reports directly to the SVP of Quality and Regulatory and is responsible for establishing and maintaining a compliant and efficient Quality System with emphasis on developing and executing a comprehensive software quality strategy.  This leader would work closely with various cross-functional partners, in particular with R&D and their software testing team to ensure our Artificial Intelligence (AI) Software as Medical Device (SaMD) products meet the highest standards of safety, performance, and compliance.

You will lead a team of Design Quality Engineers and Quality System and Quality Compliance Managers and engineers, fostering a culture of quality across the entire software development lifecycle. The ideal candidate has deep experience in the medical device industry and Quality, SaMD devices, and a proven track record of navigating complex regulatory landscapes, including FDA, PMDA, IEC, and ISO standards.

Job Responsibilities:

Strategic Leadership & Team Development

  • Lead, mentor, and scale a high-performing team of Design Quality Engineers and 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, 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.

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 requirements.
  • Oversee key QMS subsystems, including Design Control and Risk Management. 
  • Drive continuous improvement initiatives to enhance the efficiency and effectiveness of the QMS.

Software Design Quality & Risk Management

  • Architect and execute the software design control and risk management strategy for Heartflow’s AI-based SaMD products to ensure compliant and efficient design and development processes. 
  • Provide expert guidance to the R&D teams on design controls, requirements definition, V&V testing strategies, and software traceability.
  • Oversee the maintenance and integrity of the Design History File (DHF). 
  • Lead risk management activities in accordance with ISO 14971, ensuring a proactive approach to identifying and mitigating product risk throughout the lifecycle.

Compliance & Audits

  • Serve as the primary subject matter expert (SME) for the QMS and software quality during all internal and external audits, including inspections by the FDA, Notified Bodies, and other regulatory authorities.
  • Ensure all software quality documentation for regulatory submissions are robust, compliant, and delivered on time.

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 Design Control and Risk Management processes. 

Educational Requirements & Work Experience: 

  • Bachelor's degree in an engineering or scientific discipline (e.g., Computer Science, Software Engineering, Biomedical Engineering).
  • 12+ years of progressive experience in Quality within the medical device industry, with at least 7+ years in a leadership/management role.
  • Significant experience with Quality for Software as a Medical Device (SaMD) or software-intensive medical devices.
  • 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).
  • Deep expertise in modern software development lifecycle (SDLC) processes within a regulated framework, including risk management and verification/validation strategies.
  • Exceptional leadership and communication skills, with a demonstrated ability to influence and build consensus among cross-functional senior leaders.

Preferred:

  • Master’s degree or other advanced degree.
  • Direct experience with AI/ML-driven SaMD and cloud-based (e.g., AWS, Azure) 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, Agile development environment.

A reasonable estimate of the base salary compensation range for the San Francisco Bay Area is $220,000 to $270,000 per year. 

We are open to considering senior level Director for the right candidate, reflecting their extensive experience and proven expertise in the field.

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/. 

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