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.

Requirements:

• 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.

Thermo Fisher Scientific offers competitive compensation and benefits packages, along with ample opportunities for professional growth and development. As an equal opportunity employer, we value inclusivity and strive to create an environment where everyone can thrive. We are committed to providing reasonable accommodations/adjustments for individuals with disabilities during the application and interview process.

If you are passionate about delivering exceptional customer experiences and driving customer advocacy, we invite you to apply for the Quality Specialist I position and join us in our mission to make the world healthier, cleaner, and safer.