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HeartFlow is a publicly traded medical technology company (HTFL) pioneering AI-driven solutions for coronary artery disease diagnosis and management. The company's flagship product, HeartFlow FFR_CT Analysis, is a non-invasive cardiac test that provides 3D visualization of coronary arteries and blood flow assessment. Used by over 500,000 patients globally, the platform is cleared in the US, UK, Europe, Japan, and Canada.
As Senior Manager of Quality System & Compliance, you will lead the strategy, execution, and continuous improvement of HeartFlow's Quality Management System (QMS) and ensure robust compliance with FDA, ISO 13485, EU MDR, MDSAP, and other international medical device regulations. This is a pivotal leadership role combining strategic foresight with tactical execution, with particular expertise needed in Software as a Medical Device (SaMD) QMS frameworks.
Key responsibilities include:
**QMS Oversight:** Manage all aspects of the QMS to ensure global regulatory compliance. Oversee critical subsystems including CAPA, document control, training, management review, internal audits, external audit management, QMS tool validation, and supplier management. Drive continuous improvement initiatives to enhance QMS efficiency and effectiveness.
**Quality Compliance & Audits:** Serve as the primary subject matter expert (SME) for the QMS during regulatory inspections by the FDA, Notified Bodies, and other authorities. Lead audit preparation and response efforts. Prepare the organization for appropriate quality compliance levels to support global expansion.
**Strategic Leadership & Team Development:** Lead, mentor, and scale a team of QMS professionals while fostering career growth and technical excellence. Champion a "Quality-first" culture throughout the organization using data-driven KPIs and accountability metrics. Collaborate cross-functionally with R&D, Production, Regulatory, Clinical, and Product Management to integrate quality processes seamlessly. Manage departmental resources, headcount planning, and long-term strategic initiatives.
Required qualifications: Bachelor's degree in engineering or scientific discipline. 10+ years of progressive quality experience in medical devices with 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 leading or playing key SME roles in FDA and Notified Body inspections. Exceptional leadership and cross-functional influence skills.
Preferred: Direct experience with AI/ML-driven SaMD and cloud-based medical device platforms. Familiarity with medical device cybersecurity standards (AAMI TIR57) and data privacy regulations.
