Quality Specialist
Core
Ensure design transfer to manufacturing, conduct product marketing release, and manage production quality compliance for medical devices.
Role type
Quality Specialist (Medical Device Manufacturing)
Builds
Medical device products compliant with regulatory standards
Domain
Medical Devices / Biomedical Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 13485 compliance, GMP regulations, NMPA registration, CAPA management, root cause analysis, audit execution, supplier evaluation, UDI data maintenance
Preferred skills
Mechanical engineering background, design transfer experience, internal/external audit support, MAH project experience
Technologies
NMPA system
Responsibilities
Ensure design transfer to manufacturing, conduct product marketing release, perform manufacturing process audits, lead product complaint investigations, prepare quality documentation and reports, support quality system initiatives, maintain UDI data
Seniority
Mid-level, hands-on IC
