Quality Specialist

: 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 . 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.

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