Senior Manager, Quality System & Compliance

Senior Manager, Quality System & Compliance 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 FFR CT 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 (FFR CT 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 500,000 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. Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in Heartflow’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 07/31/2029 Why are you being asked to complete this form? We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Disability Status Select... PUBLIC BURND STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete. #J-18808-Ljbffr Heartflow