Senior Manager, Quality System & Compliance

The role

You will lead the strategy, execution, and continuous improvement of the Quality Management System (QMS). You will manage a team of quality professionals to ensure compliance with global medical device regulations.

What you will do

• Manage holistic aspects of the QMS to ensure compliance with global regulations.
• Oversee QMS 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.
• Serve as the front room or backroom lead and primary SME for the QMS during audits.
• Prepare the organization for quality compliance to U.S. and international requirements.
• Lead, mentor, and scale a team of QMS professionals.
• Champion a Quality-first mindset through collaboration and KPIs.
• Collaborate with leaders in R&D, Production, Regulatory, Clinical, and Product Management.
• Manage departmental resources including headcount and long-term strategic planning.

Required qualifications

• Bachelor's degree in engineering or scientific discipline, or equivalent.
• 10+ years of progressive experience in Quality within the medical device industry.
• 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 playing a key SME role in regulatory inspections (FDA, Notified Body).
• Effective, clear, and concise communication skills.
• 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.

Nice to have

• 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.

About the company

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using cutting-edge technology. It is a publicly traded company (HTFL) with an AI-driven cardiac test used for more than 750,000 patients worldwide.