QA specialist

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.

-  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 (e.g.Korean 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 follow up on audit findings in cooperation with stakeholders.

- Sop authoring

- Auditing / Audit response writing 

- CAPAs /NCs/Deviations 

-  Bachelor’s degrees in science, medicine and medical science preferred

-  Preferably at least 1 years of QA experience in medical device or pharmaceutical of multinational companies

-  GMP Experience in audit& inspection preferred

-  Relevant territory qualifications (e.g. science, engineering, pharma)

-  Organized, good management and planning skills

-  Ability to work closely with people at all levels

-  Excellent communication skills