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

QA Specialist

Key skills