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Job ID :
43347BR
Location :
South Korea - Seoul
:
Job Description

QA Responsibilities

  • Oversight of quality personnel assigned to each of the Divisions within S. Korea to ensure compliance with MFDS regulations for imported products.
  • Prepare Quality Records, including product inspection, import and release, including returned products, as needed.
  • Supervise label management to eliminate risk associated with local labeling process
  • Develop and maintain Quality Management System in compliance with MFDS regulatory and internal requirements.
  • Responsible for product complaints, including receiving and reporting complaints to appropriate manufacturing sites, following up on complaint investigation, and preparing customer response letter in local language. Execute and manage NCR and CAPA as necessary
  • Implement Quality holds as needed and work with manufacturing site QA and RA teams for field actions and recalls
  • Assist in the preparation of post market reports and submissions such as recall, adverse event report and complaint
  • Train Korean organization of MFDS regulations and quality requirements
  • Audit/monitor internal quality compliance level, as well as daily quality performance
  • KGMP inspections for foreign manufacturing sites
  • Prepare site for random audits of Quality System by MFDS

RA Responsibilities
  • Registration of products per regulations and communication with government officials
  • Submissions to support nHTA and HIRA registrations to enter the medical market
  • Clinical trial preparation for MFDS, nHTA and HIRA registrations
  • Maintenance of records on legislation, regulations, guidelines and regulatory files; updates & maintenance of paper/electronic document archival systems
  • Product type testing in Korean test laboratories to support product approval
  • Work with internal & international project teams in all Thermo Fisher Scientific Divisions to provide guidance on regulatory requirements to key stakeholders
  • Provide regulatory input to product lifecycle planning and communicate regulatory information to stakeholders

Requirements/Education :
  • Bachelor degree or higher degree in related field
  • Microbiology, Molecular Biology and Bioscience Background is preferred
  • 2-5 years working experience in quality & regulatory in the medical device field
  • In-depth knowledge of local regulations, ISO13485 and GMP
  • In-depth knowledge of MFDS regulations, nHTA processes and HIRA inspection
  • Strong oral and written communication in English and Korean
  • Able to work, under pressure and flexible working hours based on business requirements
  • Independent, proactive and able to work in a matrix environment
  • Good analysis skill on data trending and data segment
  • Good root cause analysis and problem solving skill


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