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.
Required Experience:
Senior IC