Heartflow
Sr. Manager - Quality System & Compliance
Heartflow, San Francisco, California, United States, 94199
Sr. Manager - Quality System & Compliance
Get AI-powered advice on this job and more exclusive features. Base pay range $185,000.00/yr - $245,000.00/yr 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 (RoadMapAnalysis), 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. Position : 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 blends strategic foresight with tactical leadership, requiring deep expertise in QMS setup and management, particularly for Software as a Medical Device (SaMD). 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: Direct all aspects of the QMS to ensure compliance with global regulations, including FDA, ISO 13485, EU MDR, and MDSAP countries’ requirements. Oversee QMS subsystems: CAPA, 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 front room or backroom lead and 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 appropriate levels 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; collaborate and use KPIs to drive accountability and data-driven decisions. Collaborate with R&D, Regulatory, Clinical, and Product Management to integrate quality processes with business objectives. Manage departmental resources, including headcount and long-term strategic planning. Skills Needed : Effective, clear, and concise communication across leadership levels. 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 FDA 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971. Proven track record of leading or contributing as an SME in regulatory inspections (FDA, Notified Body). Strong leadership and communication skills with the ability to influence 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. 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. Positions posted for Heartflow are not intended for or open to third party recruiters / agencies. Submission of unsolicited resumes will be considered free referrals. Heartflow has issued a fraud alert regarding impersonation of Heartflow recruiters. Before providing personal information, verify that recruiter emails end with @heartflow.com and that the position is listed on our careers site at www.heartflow.com/about/careers/. Seniority level
Director Employment type
Full-time Job function
Quality Assurance Industries: Medical Equipment Manufacturing
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Get AI-powered advice on this job and more exclusive features. Base pay range $185,000.00/yr - $245,000.00/yr 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 (RoadMapAnalysis), 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. Position : 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 blends strategic foresight with tactical leadership, requiring deep expertise in QMS setup and management, particularly for Software as a Medical Device (SaMD). 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: Direct all aspects of the QMS to ensure compliance with global regulations, including FDA, ISO 13485, EU MDR, and MDSAP countries’ requirements. Oversee QMS subsystems: CAPA, 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 front room or backroom lead and 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 appropriate levels 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; collaborate and use KPIs to drive accountability and data-driven decisions. Collaborate with R&D, Regulatory, Clinical, and Product Management to integrate quality processes with business objectives. Manage departmental resources, including headcount and long-term strategic planning. Skills Needed : Effective, clear, and concise communication across leadership levels. 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 FDA 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971. Proven track record of leading or contributing as an SME in regulatory inspections (FDA, Notified Body). Strong leadership and communication skills with the ability to influence 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. 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. Positions posted for Heartflow are not intended for or open to third party recruiters / agencies. Submission of unsolicited resumes will be considered free referrals. Heartflow has issued a fraud alert regarding impersonation of Heartflow recruiters. Before providing personal information, verify that recruiter emails end with @heartflow.com and that the position is listed on our careers site at www.heartflow.com/about/careers/. Seniority level
Director Employment type
Full-time Job function
Quality Assurance Industries: Medical Equipment Manufacturing
#J-18808-Ljbffr