LOCATION: Seoul, S. Korea
Job Title : QA specialist
The QA specialist will be responsible for providing oversight and guidance for both Medical Devices’ Quality Systems and Regulatory Affairs at the Seoul, South Korea facility for products being imported into South Korea for all divisions within Thermo Fisher Scientific. The role will have solid line responsibility to Regulatory Affairs for quality and regulatory compliance.
In addition to providing oversight, the role will be required to carry-out the following job responsibilities for QA to ensure compliance with MFDS import requirements, post-market surveillance and compliance activities.
- Oversight of quality personnel assigned to each of the Divisions within S. Korea to ensure compliance with MFDS regulations for medical devices
- 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
- Internal quality system control and documents preparation to meet the GSP (Good Suppliers Practice) requirements of medical devices
- Bachelor degree or higher degree in related field
- Bioscience, Engineering Background is preferred
- more than 5 years working experience in quality in the medical device field is preferred
- In-depth knowledge of MFDS regulations, ISO13485 and GMP
- 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