About the role

Aplyr's Quick Take

This role is about leading quality assurance efforts for medical devices and pharmaceuticals, ensuring compliance with regulations and internal standards. It's a managerial position focused on overseeing quality management systems, product release processes, and complaint handling, while collaborating with various internal and external stakeholders.

Good fit

Ideal candidates have at least 8 years of experience in quality management within the medical device or pharmaceutical sectors, with a strong grasp of relevant regulations. They should be collaborative, detail-oriented, and comfortable leading a team.

Worth noting

The role requires fluency in both Korean and English, which may limit the applicant pool. It also involves significant interaction with both internal teams and external partners, emphasizing the need for strong communication skills.

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.

Aplyr's read

Fresenius Medical Care excels in renal healthcare, providing specialized dialysis products and services. It attracts professionals dedicated to enhancing patient care and healthcare technology.
Synthesized from recent postings & public sources

What's promising

•Leader in dialysis products, ensuring high-quality care for chronic kidney failure patients.
•Global presence offers diverse career opportunities across healthcare and technology sectors.
•Strong focus on innovation in renal healthcare solutions and patient care services.

What to watch

•Highly specialized industry may limit career growth for non-healthcare roles.
•Regulatory challenges in healthcare can impact operational flexibility.
•Dependence on healthcare reimbursement policies poses financial risks.

Why Fresenius Medical Care

•Largest provider of integrated dialysis services globally, setting industry standards.
•Combines product manufacturing with patient care, offering comprehensive renal solutions.
•Innovative in healthcare technology, enhancing patient outcomes and operational efficiency.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Fresenius Medical Care

Fresenius Medical Care

freseniusmedicalcare.com

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Fresenius Medical Care is a global leader in providing products and services for individuals with renal diseases. The company specializes in dialysis products and services, offering comprehensive care for patients with chronic kidney failure.