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.
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
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
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