Sr. QA specialist
Core
Establish and maintain the Quality Management System (QMS) for medical devices, ensuring compliance with MFDS regulations and internal standards while managing product safety, complaints, and recalls.
Role type
Senior Quality Assurance Specialist (Medical Devices)
Builds
Compliant medical device product lines and regulatory documentation
Domain
Medical Technology / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
MFDS regulations, KGMP/DGMP compliance, ISO 13485 standards, complaint management, UDI system compliance, field actions and recalls, 3PL quality monitoring, audit leadership
Preferred skills
Medical Engineering or Biomedical Science background, post-market vigilance, regulatory inspection representation
Technologies
MFDS regulatory frameworks, KGMP/DGMP certification systems, UDI databases
Responsibilities
Develop and maintain the Quality Management System (QMS) in compliance with MFDS regulations; Drive registration and maintenance of labeling and UDI data; Manage the full lifecycle of product complaints and adverse event reporting; Prepare and manage Quality Records for product inspection, import, and release; Implement Quality Holds and execute field actions and recalls; Work to maintain and renew KGMP/DGMP certificates; Monitor quality compliance levels of contracted 3PLs; Conduct quality training for internal and external stakeholders
Seniority
Senior, hands-on IC
