[Vision] Sr. QA Specialist
Core
Lead Quality Management System (QMS) compliance and regulatory affairs for medical device importer operations in Korea.
Role type
Senior Individual Contributor Quality Assurance Specialist
Builds
Quality compliance frameworks and regulatory documentation for medical devices
Domain
Medical Devices / Regulatory Compliance
Required skills
QMS management, KGMP/ISO 13485 compliance, regulatory documentation control, CAPA management, adverse event reporting, audit execution, stakeholder communication
Preferred skills
Multinational medical device experience, strategic risk management
Technologies
None stated
Responsibilities
Execute KGMP certification and renewals, manage document control for SOPs and quality records, handle complaints and nonconformances, conduct product release inspections, perform adverse event reporting, lead internal and external audits, provide quality training, liaise with global HQ and regulators
Seniority
Senior, hands-on IC