Quality Specialist

Job Description

Position: Quality Specialist

Reports To: Quality Manager

Location: Yeongjongdo (Incheon)

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:

• Responsible for ensuring compliance with Product quality inspection, Non-conforming product control and product labeling control
• Maintains warehouse management for infrastructure and work environment according to ISO 13485 or equivalent standard
• Maintain Quality Management System in compliance with MFDS and other authorities’ regulatory and internal requirements.
• Maintains the QMS system to ensure compliance with current regulations and standards and approval according to ISO 13485.
• 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
• 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:

• Bioscience, Engineering Background is preferred
• More than 2 years working experience in quality in the medical device or medicine field is preferred
• Well organized and structured.
• Ability to use some or all the following PC applications: Word, Excel, PowerPoint.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today! http://jobs.thermofisher.com

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.