Quality Specialist
Core
Ensure design transfer to manufacturing, conduct product marketing release, and act as SME in production quality management for medical devices.
Role type
Quality Specialist (Medical Device Manufacturing)
Builds
Medical device products compliant with ISO 13485 and local GMP regulations
Domain
Medical Devices / Biomedical Engineering
Required skills
ISO 13485 compliance, NMPA GMP knowledge, manufacturing process auditing, CAPA management, root cause analysis, supplier evaluation, UDI data maintenance
Preferred skills
Mechanical engineering background, design transfer experience, internal/external audit support, MAH project experience
Technologies
NMPA system, ISO 13485, GMP frameworks
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