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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



Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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