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Job ID :
58964BR
Location :
South Korea - Seoul
:
Job Description

Position Overview

The quality specialist will be required to carry-out the following job responsibilities of medical devices to ensure compliance with MFDS import requirements, post-market surveillance and GSP compliance activities.

Responsibilities

  • Product Review to classify the medical devices and non-medical devices to meet GSP requirements
  • Product control to meet Korea regulations of each product classification
  • Label manage to eliminate risk associated with local labeling requirement
  • Communicate with manufacturing sites’ QA and RA teams
  • Assist in the preparation of post market reports and submissions such as recall, adverse event report and complaint
  • Prepare site for random audits of MFDS and other government authorities
  • Prepare quality records, including product inspection, import and release, including returned products for devices

Requirements/Education

  • Bioscience, Engineering Background is preferred
  • Work experience in quality in the medical device field is preferred
  • 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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