Quality Engineer
Core
Design, implement, and continuously improve the Quality Management System (QMS) for AI-enabled medical devices to ensure safety, compliance, and scalability across design, manufacturing, and post-market activities.
Role type
Quality Engineer (Medical Devices)
Builds
AI-enabled medical devices and software solutions
Domain
MedTech / Medical Devices / Regulatory Compliance
Deliverable
production ML models
Required skills
ISO13485, 21 CFR Part 820, MDSAP, ISO14971 risk management, QMS design and implementation, supplier quality management, nonconformance and CAPA management, root cause analysis, audit execution (internal/external), regulatory submissions, software validation
Preferred skills
Machine Learning principles, experience with software/electronics/mechanical hybrid devices
Technologies
ISO13485, 21 CFR Part 820, MDSAP, ISO14971
Responsibilities
Design and maintain the Quality Management System; lead workstreams for site certification and regulatory compliance; draft and review QMS procedures and work instructions; act as QA/QC representative for manufacturing and software validation; manage supplier quality agreements and performance assessments; handle nonconformances, complaints, and lead CAPA implementation; conduct and support internal and external audits; perform root cause analysis and corrective actions.
Seniority
Mid-level, hands-on IC
