Quality Engineer
Core
Ensure quality system requirements are effectively implemented, maintained, and continuously improved for a medical device (FFRangio System) in a regulated environment.
Role type
Quality Engineer (Medical Devices)
Builds
FFRangio® System (AI-driven coronary physiologic assessment tool)
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features
Required skills
Design controls, CAPA management, Complaint handling, Software validation, Regulatory compliance (FDA/MDR/ISO 13485), Root cause analysis, Process harmonization
Preferred skills
QMS integration, Electronic QMS platforms, Software development lifecycle in regulated environments
Responsibilities
Align and implement design control processes; Support mapping and harmonization of quality system processes; Participate in CAPA and complaints handling integration; Support software development lifecycle processes; Ensure processes meet regulatory requirements; Update quality documentation and support continuous improvement.
Seniority
Mid-level, hands-on IC
