Quality Specialist

Job Description

POSITION SUMMARY

The Quality specialist will be responsible for providing oversight and guidance for the quality systems and compliances for products being imported into South Korea within Thermo Fisher Scientific, and domestic sales business.

Key Responsibilities:

• Maintains and updates the QMS system to ensure compliance with current regulations and standards and approval according to ISO 13485.
• Maintains warehouse management for facility and environment according to ISO 13485 or equivalent standard
• Develop and maintain Quality Management System in compliance with MFDS and other authorities’ regulatory and internal requirements.
• Quality documents and quality records, ensure the latest version of quality documents should be maintained and used at work as well as quality records management
• Support for that ISO certification and related activities performed as professional and efficient survey, validation, etc. & supports quality management review meeting
• Be key auditee from internal and external audit regarding Quality Management System.
• Audit/monitor internal quality compliance level, as well as daily quality performance
• Management of customer facing quality processes to provide timely and professional reply to customer complaints, requests for information, host of audits, quality agreements etc.
• Prepare site for random audits of Quality System by MFDS
• GSP management for domestic sales business and review the products to meet the MFDS requirements of medical devices.

Qualifications:

• Bachelor degree or higher degree in related field
• Bioscience, Engineering Background is preferred
• More than 6 years working experience in quality in the medical device or medicine field is preferred
• Well oral and written communication in English and Korean
• Independent, proactive and able to work in a matrix environment
• Well organized and structured.
• Ability to use some or all the following PC applications: Word, Excel, PowerPoint.

Benefits:

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

EEO/Reasonable Accommodation:

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.