Job Description
Overview
This position will serve as QA specialist at Cook Medical Korea and have responsibilities for managing quality assurance system throughout the imported products based on global and local regulations.
Responsibilities
- Implement continuous quality improvement initiatives in line with MFDS regulation and all regulatory requirements relevant to sales of Cook products
- Coordinate activities to direct, control and maintain the company’s accreditations ( GMP, Ad-hoc audits)
- Disseminate quality assurance trends and information to key CMK RAQA Manager to ensure the organization is up to date with current quality requirements
- Maintain and update internal quality documents in a timely manner.
- Recall & Complaint handling of Cook products and report local & overseas adverse event to MFDS in cooperation with RA, Sales, Overseas manufacturer, Supply chain.
- Arrange local distributor audit and fol...