Job Description

You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.
QA Specialist
Company:  B. BRAUN KOREA CO. LTD.
Job Posting Location:  Gangnam-gu, Seoul Teugbyeolsi, Korea
Functional Area:  Quality
Working Model:  Onsite
Requisition ID:  7509

Are you a QA passionate about Medical products? If so, this opportunity could be for you! Join us in at B. Braun Korea, a leader in the medical devices industry, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare!  
As a QA Specialist at B. Braun you will play a vital role in ...

 

Medical Device Quality Assurance

 

1. Responsible for post-market surveillance activities for Medical device in B. Braun

  1. Process the adverse event occurred in the field incl. reporting to local authority and
  2. relevant manufacturer and Global Safety Officer.
  3. Report serious adverse event from overseas to local authority
  4. Manage field action regarding product recall/correction including report to MFDS
  5. Manage the product complaints incl. reporting to local authority and manufacturers, communication with customers etc
  6. Provide the complaint/vigilance training to relevant stakeholders and internal employees as planned

2. Ensure product quality and performance of product groups in compliance with Medical Device law and Corporate QMS.

  1. Conduct self-audit and supplier audit as planned
  2. Conduct inspection for product release and Block management
  3. Maintain the Korean label and inserts (IFU, eIFU) in line with product registration and local regulations.
  4. Perform inspection for second-hand medical device release
  5. Coordinate with 3PL (3rd Party Logistics) to maintain high quality of imported medical devices
  6. Collaborate with internal stakeholders to pursue alignment regarding company
  7. processes and policy for the quality of medical devices

3. KGMP maintenance

  1. Renewal of KGMP certification when required
  2. KGMP certification when site been added/modified, if required.
  3. Establish, maintain and implement quality management system incl. processes and records in compliance with KGMP and corporate QMS.

 

What you will bring to the team:  

Experience

  1. Minimum 3-6 years QA or relevant experience in healthcare or medical device industry preferred.
  2. Multinational company experience preferred
  3. Specific knowledge /skills
  4. Communication and interpersonal skills
  5. Good command of spoken and written English
  6. Knowledge of the quality system of Medical device and related local regulations.
  7. Ability to work under competing priorities and to work cross functionally

 

Benefits

  • Healthcare 산업군 내에 경쟁력 있는 Benefit 제공
  • 선택적 근무 제도, 조기 퇴근제 및 재택 근무제 운영영
  • Flexible Benefit 수당 (복지카드 제공)
  • 통신비 지원
  • 생일 상품권 제공
  • 건강검진 제공
  • 경조사금 및 휴가
  • 자녀학자금 (고등학교, 대학교)
  • 장기근무 포상
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