General Responsibilities

Lead the implementation and continuous improvement of the Quality Management System (QMS) for both medical device and pharmaceutical products at Fresenius Medical Care Korea.

Ensure compliance with Ministry of Food and Drug Safety (MFDS) regulations, ISO 13485, GMP, GSP, and corporate standards.

Oversee product release, labeling, documentation, and distribution quality across internal and third-party warehouses.

Manage product complaints, trend analysis, and recall processes in alignment with global procedures.

Maintain strong relationships with internal stakeholders (RA, PV, SCM, BU Heads) and external partners (manufacturers, distributors, laboratories).

KEY RESPONSIBILITIES

1) QMS & Compliance

Develop, maintain, and audit SOPs, quality protocols, and the Korean DMR.

Oversee internal audits, post-market surveillance, field safety corrective actions, and regulatory submissions.

2) Product Quality & Release

Review batch records, certificates of analysis, and release documentation.

Approve product release status in the internal system.

Supervise incoming inspection and storage condition monitoring.

3) Complaint & Risk Management

Investigate customer complaints and report to global systems.

Conduct trend analysis and coordinate recall activities.

4) Warehouse & Distribution Quality

Perform regular on-site warehouse inspections and manage training of warehouse staff.

Ensure quality compliance for distribution, value-added services, and third-party operations.

5) Leadership & Collaboration

Lead the local QA team and coordinate Korea QA initiatives.

Collaborate closely with RA, PV, SCM, and commercial teams.

Provide quality system training to internal teams.

Required Qualifications

Bachelor's degree or higher in Biotechnology, Biomedical Engineering, Biomedical Science, Pharmacy, or related scientific/engineering fields.

Minimum 8 years of quality management experience in the medical device and/or pharmaceutical industry.

Strong understanding of ISO 13485, GMP, GSP, MFDS regulations.

Excellent communication skills (Korean & English).

Ability to collaborate cross-functionally and engage with medical sites when required.