Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Position summary:

In the role of Senior Quality Specialist at Thermo Fisher Scientific Inc., you will be fundamental in upholding the top-notch quality management of our products. This position manages the quality control of incoming inspections and assists in post-market surveillance, supporting our vision of fostering a healthier, cleaner, and safer world!

Key Responsibilities:

Lead the quality operations for all products and manage the disposition of nonconforming products.Monitor and manage incoming inspections, ensuring products are released according to inspection results.Coordinate supervision and quality management activities with third-party warehouses.Support the management of post-market surveillance, including handling complaints and coordinating investigations and responses.Prioritize or coordinate medical device recalls.Implement medical device quality safety risk consultations, such as periodical risk evaluation reports.Submit and report adverse events related to medical devices.

Qualifications:

College Degree or higher in medical laboratory inspection or related fields such as laboratory science, biomedical engineering, biochemistry, immunology, genetics, pharmacy, biotechnology, clinical medicine, or medical devices.License of chief medical/laboratory technician.Over 3 years of professional work experience in clinical inspection.Knowledge of GSP and ISO 13485.Proficiency in English, both reading and writing.