Ensure compliance with MFDS requirements, including post-market surveillance, labeling, importer duties, QMS maintenance, and proper product release to customers.

Manage the QA team in performing post-market activities such as product complaints, field actions, and adverse event reporting, ensuring compliance with standards.

Responsible for maintaining ISO 13485 certification for Stryker Korea.

Serve as the key auditee during internal or external quality audits, ensuring successful outcomes.

Lead quality activities, including internal audits, supplier audits, CAPA, customer surveys, validation, and Quality Management Review meetings. Ensure proper maintenance of quality documents and records.

Oversee the quality management system of 3PL to meet internal and external requirements, including product labeling, storage, and

Responsible for order processing in line with company quality and ethical standards.

Provide excellent customer service, ensuring customer satisfaction and coordinating sales activities.

Collaborate closely with stakeholders such as Commercial, Customers, RAQA, EA & APAC teams, Finance, IT, and more.

Requires extensive experience and knowledge in logistics, inventory management, ERP, and project management.

Key metrics include order entry accuracy, OTIF, and billing accuracy.