Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Position: Quality specialist
Reports To: Quality Manager
Location: Suseo office (Seoul)
POSITION SUMMARY
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The Quality specialist will be responsible for customer related support, quality monitoring and record control and reporting duties for the quality management systems and compliances.
Key Responsibilities:
- Management of customer facing quality processes to provide timely and professional reply to customer requests for information, host of audits, quality agreements, supplier questionnaire etc.
- 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
- Daily/monthly/Annual Quality important metrics monitoring and record keeping
- Annual/monthly on time reports of medical devices and IVD to the MFDS
- 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 and IVD.
- 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.
Qualifications:
- Bachelor degree or higher degree in related field
- Bioscience, Engineering Background is preferred
- More than 1 year working experience in Quality and Regulatory in various sectors (Pharmaceutical, healthcare, FMCG, etc.) is preferred
- Oral and written communication in English and Korean
- 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.