Quality

Quality Assurance Manager

Address: 14F, FKI Tower, 24, Yeoui-daero, Yeongdeungpo-gu, Seoul,  07320, Korea, Republic of

Job ID: R0242700

Location Type: Hybrid

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  • Overview
  • Job Description
  • Success Profile
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As a Clinic Manager at Fresenius Medical Care, you’ll manage the daily operations of our outpatient centers. More importantly, you’ll be the key driver in carrying out our mission: To deliver superior care that improves the quality of life of every patient, every day, setting the standard by which others in the health care industry are judged. This is accomplished by hiring, developing and inspiring a multi-disciplinary team, collaborating with physicians, tracking and delivering superior patient outcomes and monitoring regulatory and safety requirements. Strong management skills are required and prior direct patient care experience is needed for occasions when the team needs a helping hand.

A female nurse examining her patient

Patient Care Technicians (PCTs) at Fresenius Medical Care support and collaborate with RNs to provide dialysis treatment to several patients at a time while maintaining the functionality of the clinic. This involves prepping and testing equipment, reviewing treatment sheets, and opening the clinic at 4am for first shift. PCTs have a combination of technical skills and genuine passion needed to develop deep relationships with patients and improve their quality of life. Qualified candidates have prior customer service, healthcare and direct patient care experience, and will have the opportunity to learn the discipline of dialysis.

A female nurse examining her patient

Fresenius Medical Care nurses are on the front line of patient care, improving the quality of life of every patient, every day. That means providing dialysis care to 10-12 patients at any given time, and collaborating with our multi-disciplinary team to deliver a unique care plan to each one of them. This role is all about relationships and the bond you’ll create with patients and their families. Prior dialysis nursing experience is helpful, but many successful candidates come from a background in ICU, PCU and/or surgery.

A female nurse examining her patient

Inpatient RNs at Fresenius Medical Care perform dialysis treatments on an acute patient population in a hospital setting, including ICU, ER, Rehab, and Med/Surg units. What makes this role truly unique is the level of autonomy you’ll enjoy. Inpatient nurses are specifically accountable for administering and assessing each patient’s treatment plan. And because dialysis is a critical treatment for many hospital procedures and health conditions, you’ll have the opportunity to work with a wide variety of patients. Ideal candidates possess leadership skills and independence needed to make quick decisions in a fast-paced environment. Must be capable of educating patients and providing exceptional customer service to our partners. Six months to one year of dialysis experience or some form of critical care nursing experience are also required.

A female nurse examining her patient

Job Description

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.

Success Profile

What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.

Success profile proportion

Success Profile

What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.

Success profile proportion

Success Profile

What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.

Success profile proportion

Success Profile

What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.

Success profile proportion
“I successfully completed the RN program and went on to hold the position of Staff RN, Charge Nurse, and finally Clinical Manager.”
Rosalyn,
Clinical Manager
“Every day I walk in I am changing lives for the better and working to inspire my patients.”
Andrew,
Patient Care Technician
“I am a member of an outstanding team that helps patients gain more control, achieve tangible goals, and live better lives.”
Tony,
Outpatient Services RN
“My goal is to make sure that our patients keep their mobility and quality of life. This goal is really personal for me. My own father always had really bad vasculature in his leg and never had access to the kind of care we offer — eventually he lost blood flow and mobility. Knowing what he went through makes me even more committed to our mission.”
Warren J.
Azura Regional Vice President

We've got your back.

We fully believe that dedication and passion should be recognized and rewarded. That’s why we offer a competitive compensation and benefits package to all of our employees. Our benefits provide the flexibility, choice and support you need to be at your best as you play a vital part in helping patients live longer, better and healthier lives.

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