Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Thermo Fisher Scientific is looking for a committed and meticulous Quality talent to join our team in Seoul, South Korea. This role offers a one-of-a-kind chance to be a part of a renowned organization and make a valuable contribution towards our mission of promoting a healthier, cleaner, and safer world!

Responsibilities:

• Develop and maintain Quality Management System in South Korea by promoting Quality Mindset within the organization.
• Maintain the Quality Management System in compliance with regulatory (including Korea Medical Device Act) and internal requirements.
• Ensure compliance with current regulations and standards and obtaining and maintenance of ISO 13485 certification.
• Maintain organization compliant to Good Supply Pratice (GSP) and Medical Device Repairer's responsibility for domestic sales business and review products to meet MFDS requirements for medical devices and IVD.
• Audit/monitor internal quality compliance level/ KPI
• Manage quality related suppliers by supporting supplier owning functions.
• Perform internal audit as an internal auditor.
• Support other functions in developing procedures, including purchasing, customer service, etc.
• Serve as a back up for handling customer complaints and quality inquiry.

• Excellent command of English is required.
• Bachelor's degree in a relevant field or equivalent experience.
• Proven experience in quality assurance.
• Strong attention to detail and ability to manage multiple tasks.
• Excellent communication and problem-solving skills.
• Knowledge of MFDS regulations and ISO 13485 standards is preferred.