J&J Family of Companies [Medical] Associate QA Specialist in Yongsan-gu, South Korea

Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

  1. 포지션: Associate QA Specialist

  2. 계열사: 존슨앤드존슨 메디칼 (Medical Devices)

  3. 근무지: 서울시 용산구


Quality Assurance & Quality System

  • Execute quality assurance programs designed to ensure continuous distribution of products consistent with established standard.

  • Performs quality support duties for quality system management including maintenance of the corrective action and preventive action (CAPA)

  • Provides support for special quality projects such as new standard deployment, process change for new regulatory requirements, etc.

Complaint Handling

  • Receive product complaints via internal system, phone, email, and oral communication and input the information into database

  • Communicate with quality engineers, manufacturers, and sales representatives to capture and document detailed complaint information for investigation

  • Coordinate the return of complaint devices from the market by collaboration with commercial team and customer service team

  • Arrange for inspection and packing of the returned devices and ship the products to overseas decontamination/evaluation labs for analysis

  • Document and maintain data related to complaint handling activities

  • Prepare monthly complaint monitoring analysis report for announcement

  • Prepare complaint analysis results for management review twice a year

  • Examine and determine the trend of complaints by products, frequencies, or any outstanding problems

  • Provide guidance and directions to internal employees and external distributors for handling and reporting of complaints

  • Assist government inspections on medical devices, drugs, and quasi-drugs regulatory compliance

  • Assist corporate audits on enterprise quality policy standards compliance

  • Communicate with Health Authority (MFDS) regarding complaint investigation results and CAPA status for adverse events directly reported to MFDS from hospitals


  • Minimum Bachelor’s degree is required.

  • Experience in Quality or Regulatory Affairs is preferred (not mandatory).

  • Knowledge of quality system and regulatory environment.

  • Excellent communication and strong interpersonal skills.

  • Experience preferred from a multi-national or regional company.

  • Fluent in English both oral or written.

  • Manages activities within Enterprise Complaint Management(ECM) system.

  • Maintains complaint handling procedures and forms and revises those, if required

  • Supports audits and inspections.

[JD 확인 및 지원 방법]

www.careers.jnj.com -> Requisition number 1805633639W 검색 -> 해당 모집 공고 클릭 후, “Apply Now”

[제출 서류]

영문 자유 양식의 이력서/자기소개서

[서류 마감일]

채용시 마감


  • 서류를 MS-Word 나 PDF 로 된 한 개의 파일로 미리 준비 하시기 바랍니다.

  • 서류 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 지연 될 수 있습니다.

  • 모집 분야 관련하여 자세한 내용은 J&J 홈페이지에서 확인하시기 바랍니다. www.careers.jnj.com

[이메일 문의]



See Above

Primary Location

South Korea-Seoul-Yongsan-gu


Johnson & Johnson Medical Korea (Ltd.) (7225)

Job Function

Quality (Generalist)

Requisition ID