Quality Assurance Specialist
QIAGEN
Seoul, South Korea
2 일 전

Overview

QIAGEN is one of the world’s most successful biotech companies and has achieved outstanding growth in its industry. As a worldwide leading provider of innovative DNA, RNA, and protein purification technologies and molecular testing solutions to the life science market and to diagnostic laboratories, we have consistently delivered impressive year-on-year revenue increases.

Position Description

  • Act as Quality Manager of QIAGEN Korea and lead Quality System Audits by MFD and Notified Bodies.
  • Maintain the Quality System according KFDA regulation for Medical Devices and In-Vitro Diagnostic products and maintain Quality Records.
  • Act as Quality Control of imported Products
  • Maintain Manual of import management standard and maintain import product release record
  • Maintain Manual of product specification

  • Oversee country specific labeling of imported MD and IVD products including GHS labeling
  • Position Requirements

  • Scientific or Engineering degree in Biology, Chemistry or other life science discipline
  • 3- 5 year experience in Medical Device or Diagnostic Industry, preferred.
  • Experience in Quality Assurance.
  • Good knowledge of the regulatory environment in Korea
  • Flexible working time to communicate to a global QA network
  • Personal Requirements

  • Good team player in an international environment
  • Curious to lean in a fast changing industry
  • Customer focused and target oriented working style
  • Decision maker able to work independently
  • Good English communication skills
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