Sr. QA specialist
Core
Establishing and maintaining the Quality Management System (QMS) for medical devices in compliance with MFDS regulations, leading complaint management, and overseeing UDI system compliance.
Role type
Senior Regulatory and Quality Assurance Specialist (Medical Devices)
Builds
Quality assurance framework for used medical devices, product traceability, and regulatory compliance documentation
Domain
Medical Technology / Regulatory Compliance
Required skills
MFDS regulations, KGMP/DGMP compliance, ISO 13485 standards, complaint management, UDI system compliance, field actions and recalls, 3PL quality monitoring, internal/external audits
Preferred skills
Medical Engineering or Biomedical Science background, leadership in regulatory inspections, cross-functional communication
Technologies
MFDS regulatory systems, UDI databases, KGMP/DGMP certification tools
Responsibilities
Develop and maintain QMS documentation, manage labeling and UDI data, handle product complaints and adverse event reporting, prepare quality records for product release, execute field actions and recalls, maintain KGMP/DGMP certificates, monitor 3PL quality performance, conduct quality training
Seniority
Senior, hands-on IC