Senior Manager, Quality System & Compliance
Core
Lead the strategy, execution, and continuous improvement of the Quality Management System (QMS) and ensure compliance with global medical device regulations for an AI-driven cardiac diagnostics company.
Role type
Senior Manager, Quality System & Compliance (Regulatory)
Builds
AI-driven non-invasive cardiac test solutions (Heartflow FFRCT Analysis, RoadMap Analysis, Plaque Analysis)
Domain
Medical Technology / Cardiovascular Diagnostics / Software as a Medical Device (SaMD)
Deliverable
production ML models | infrastructure
Required skills
QMS setup and management, FDA 21 CFR 820, ISO 13485, IEC 62304, ISO 14971, regulatory inspection leadership, team leadership, strategic planning
Preferred skills
AI/ML-driven SaMD experience, medical device cybersecurity standards, global regulatory submissions, scaling quality processes
Technologies
FDA 21 CFR 820, ISO 13485, IEC 62304, ISO 14971
Responsibilities
Manage holistic aspects of the QMS including CAPA, Document Control, Training, Management Review, Internal/External Audits, Tool Validation, and Supplier Management; Serve as primary SME during audits by FDA and Notified Bodies; Lead, mentor, and scale a team of quality professionals; Collaborate with R&D, Production, Regulatory, Clinical, and Product Management to integrate quality processes
Seniority
Senior, hands-on IC with leadership responsibilities
