Hiring: Senior Manager, Quality System & Compliance Company: Heartflow Location: San Francisco, CA Job Posted Time: 2026-09-10 11:19:52 Employment Type: Hybrid Target Skills & Keywords : Product Management, R About the job Experience: •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. •Demonstrated success in 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. Required Skills: •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. •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. Qualifications: •Direct experience with AI/ML-driven SaMD and cloud-based medical device platforms. •Operational familiarity with medical device cybersecurity standards (e.g., AAMI TIR57) and data privacy regulations. •This position has an estimated base salary of $195,000 - $250,000, bonus, and equity. ; LI-Hybrid •Bachelor's degree in engineering or scientific discipline, or equivalent. Compensation: •$195,000 - $250,000 / year •This position has an estimated base salary of $195,000 - $250,000, bonus, and equity Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!