HeartFlow, Inc
Sr. Manager - Quality System & Compliance
HeartFlow, Inc, San Francisco, California, United States, 94199
Sr. Manager - Quality System & Compliance
HeartFlow is a medical technology company advancing the diagnosis and management of coronary artery disease with AI-driven, non-invasive cardiac testing. Our flagship product provides a color-coded, 3D model of a patient’s coronary arteries to indicate the impact of blockages on blood flow. We offer integrated solutions across the CCTA pathway to identify stenosis, assess coronary blood flow, and characterize atherosclerosis. Our pipeline of products is growing and so is our team. HeartFlow is a publicly traded company (HTFL) with international recognition for healthcare innovation and global regulatory clearance. The company has supported use in the US, UK, Europe, Japan, and Canada, with usage for more than 400,000 patients worldwide. Senior Manager of Quality System and Quality (Regulatory) Compliance
is a pivotal leadership role responsible for strategy, execution, and continuous improvement of the Quality Management System (QMS), oversight, and associated tools. This role ensures robust compliance with national and international medical device regulations, including FDA, ISO 13485, EU MDR, and MDSAP, with a focus on Software as a Medical Device (SaMD). You will lead a high-performing team of quality professionals, promote a "Quality-first" culture, and drive data-driven decisions. A proven ability to navigate regulatory landscapes (FDA, PMDA, IEC, EU MDR, ISO) is essential to success. Job Responsibilities : Quality Management System (QMS) Oversight: Direct all aspects of the QMS to ensure compliance with global regulations (FDA, ISO 13485, EU MDR, MDSAP) and applicable country requirements. QMS Subsystems: Oversee CAPA, Document Control, Training, Management Review, Internal Audits, and External Audit management. Continuous Improvement: Drive initiatives to enhance QMS efficiency and effectiveness. Quality Compliance & Audits: Act as SME for QMS during audits, including FDA inspections and Notified Body assessments. Prepare the organization for appropriate quality compliance to support global expansion. Strategic Leadership & Team Development: Lead and scale a team of QMS professionals, foster growth, and promote a data-driven quality culture with KPIs. Cross-Functional Collaboration: Partner with R&D, Regulatory, Clinical, and Product Management to integrate quality processes while balancing compliance with business goals. Resource Management: Manage headcount and long-term strategic planning for the department. Skills Needed : Clear, concise communication across leadership levels. Ability to coach and foster a collaborative quality culture. Deep understanding of Quality System and Quality Compliance. Experience interacting with auditors (FDA Investigators, Notified Bodies). Educational Requirements & Work Experience: Bachelor’s degree in engineering or science, or equivalent. 10+ years of progressive quality experience in the medical device industry, with 5+ years in a leadership/management role. Expert knowledge of FDA 21 CFR 820, ISO 13485, IEC 62304, ISO 14971. Proven track record in regulatory inspections (FDA, Notified Body). Strong leadership and communication skills with cross-functional influence. Preferred: Experience with AI/ML-driven SaMD and cloud-based medical device platforms. Familiarity with 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 fast-paced environments. A reasonable estimate of base salary for the San Francisco Bay Area is $185,000 to $245,000 per year, plus cash bonus and equity. #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, disability, medical condition, pregnancy, gender, sexual orientation, gender identity or expression, veteran status, or any status protected under law. Positions posted for HeartFlow are not intended for or open to third-party recruiters/agencies. Unsolicited resumes will be considered free referrals.
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HeartFlow is a medical technology company advancing the diagnosis and management of coronary artery disease with AI-driven, non-invasive cardiac testing. Our flagship product provides a color-coded, 3D model of a patient’s coronary arteries to indicate the impact of blockages on blood flow. We offer integrated solutions across the CCTA pathway to identify stenosis, assess coronary blood flow, and characterize atherosclerosis. Our pipeline of products is growing and so is our team. HeartFlow is a publicly traded company (HTFL) with international recognition for healthcare innovation and global regulatory clearance. The company has supported use in the US, UK, Europe, Japan, and Canada, with usage for more than 400,000 patients worldwide. Senior Manager of Quality System and Quality (Regulatory) Compliance
is a pivotal leadership role responsible for strategy, execution, and continuous improvement of the Quality Management System (QMS), oversight, and associated tools. This role ensures robust compliance with national and international medical device regulations, including FDA, ISO 13485, EU MDR, and MDSAP, with a focus on Software as a Medical Device (SaMD). You will lead a high-performing team of quality professionals, promote a "Quality-first" culture, and drive data-driven decisions. A proven ability to navigate regulatory landscapes (FDA, PMDA, IEC, EU MDR, ISO) is essential to success. Job Responsibilities : Quality Management System (QMS) Oversight: Direct all aspects of the QMS to ensure compliance with global regulations (FDA, ISO 13485, EU MDR, MDSAP) and applicable country requirements. QMS Subsystems: Oversee CAPA, Document Control, Training, Management Review, Internal Audits, and External Audit management. Continuous Improvement: Drive initiatives to enhance QMS efficiency and effectiveness. Quality Compliance & Audits: Act as SME for QMS during audits, including FDA inspections and Notified Body assessments. Prepare the organization for appropriate quality compliance to support global expansion. Strategic Leadership & Team Development: Lead and scale a team of QMS professionals, foster growth, and promote a data-driven quality culture with KPIs. Cross-Functional Collaboration: Partner with R&D, Regulatory, Clinical, and Product Management to integrate quality processes while balancing compliance with business goals. Resource Management: Manage headcount and long-term strategic planning for the department. Skills Needed : Clear, concise communication across leadership levels. Ability to coach and foster a collaborative quality culture. Deep understanding of Quality System and Quality Compliance. Experience interacting with auditors (FDA Investigators, Notified Bodies). Educational Requirements & Work Experience: Bachelor’s degree in engineering or science, or equivalent. 10+ years of progressive quality experience in the medical device industry, with 5+ years in a leadership/management role. Expert knowledge of FDA 21 CFR 820, ISO 13485, IEC 62304, ISO 14971. Proven track record in regulatory inspections (FDA, Notified Body). Strong leadership and communication skills with cross-functional influence. Preferred: Experience with AI/ML-driven SaMD and cloud-based medical device platforms. Familiarity with 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 fast-paced environments. A reasonable estimate of base salary for the San Francisco Bay Area is $185,000 to $245,000 per year, plus cash bonus and equity. #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, disability, medical condition, pregnancy, gender, sexual orientation, gender identity or expression, veteran status, or any status protected under law. Positions posted for HeartFlow are not intended for or open to third-party recruiters/agencies. Unsolicited resumes will be considered free referrals.
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