[Vision] Sr. QA Specialist
Core
Sr. QA Specialist leading Quality Management System (QMS) compliance with Corporate and Korea regulations for the Vision Care division.
Role type
Senior Individual Contributor QA Specialist
Builds
Quality compliance frameworks and regulatory adherence for medical device products
Domain
Medical Devices / Healthcare / Regulatory Compliance
Required skills
QMS management, KGMP certification, ISO 13485 compliance, CAPA management, adverse event reporting, audit execution, regulatory documentation, stakeholder communication
Preferred skills
Multinational medical device experience, strategic problem-solving, risk management
Technologies
ISO 13485, KGMP, MFDS regulations, GMP
Responsibilities
Execute KGMP certification/renewals and enhance QMS; Manage document control for SOPs and quality records; Handle complaints, nonconformances, CAPA, and trend analysis; Conduct product release processes including incoming inspection and labeling; Perform adverse event reporting and vigilance; Lead internal and external audits; Prepare data for management review; Manage compliance with MDGSP and warehouse controls; Provide quality training; Communicate with global HQ and regulators; Ensure compliance with Medical Devices Act and related regulations.
Seniority
Senior, hands-on IC