Quality Sr. Specialist

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.