About this role
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.