Senior Quality & Compliance Leader for SaMD & QMS

Heartflow; San Francisco (CA); On-site; USD 195,000 - 250,000; Full time

Job summary

Heartflow seeks a Senior Manager, Quality System & Compliance to lead the QMS strategy, execution, and continuous improvement. You will drive compliance with FDA, ISO, EU MDR, and MDSAP across SaMD and device products, guiding audits and regulatory submissions while enabling scalable growth.

You will build and mentor a high-performance quality team, promote a data-driven culture, and partner with R&D, Regulatory, and Production to balance compliance with business goals.

Qualifications

• Bachelor's degree in engineering or scientific discipline or equivalent.
• 10+ years of progressive quality experience in the medical device industry.
• 5+ years in a leadership/management role within quality.
• Expert knowledge of FDA 21 CFR 820, ISO 13485, IEC 62304, ISO 14971.
• Track record leading regulatory inspections (FDA, Notified Body).

Responsibilities

• Oversee Quality Management System (QMS) to ensure global regulatory compliance (FDA, ISO 13485, EU MDR, MDSAP).
• Lead QMS subsystems: CAPA, Document Control, Training, Management Review, Internal/External Audits, QMS Tool Validation, Supplier Management.
• Drive continuous improvement initiatives to enhance QMS efficiency and effectiveness.
• Serve as SME for audits by FDA, Notified Bodies, and other regulators.
• Prepare organization for US and international quality compliance to support global expansion.
• Lead, mentor, and scale a team of QMS professionals.
• Foster a Quality-first culture with KPI-driven accountability and data-based decisions.

Skills

Clear communication

Coaching & mentoring

Quality System expertise

Auditor interactions

Education

Bachelor's degree in engineering or scientific discipline

10+ years in medical device quality

5+ years in leadership/management

FDA 21 CFR 820, ISO 13485, IEC 62304, ISO 14971 knowledge

Regulatory inspections experience (FDA/Notified Bodies)

Job description

Heartflow seeks a Senior Manager, Quality System & Compliance to lead the QMS strategy, execution, and continuous improvement. You will drive compliance with FDA, ISO, EU MDR, and MDSAP across SaMD and device products, guiding audits and regulatory submissions while enabling scalable growth.

You will build and mentor a high-performance quality team, promote a data-driven culture, and partner with R&D, Regulatory, and Production to balance compliance with business goals.