Quality Sr. Specialist at Thermo Fisher Scientific

Candidates need a college degree or higher in fields like medical laboratory inspection, laboratory science, biomedical engineering, biochemistry, immunology, genetics, pharmacy, biotechnology, clinical medicine, or medical devices, plus a license of chief medical/laboratory technician, over 3 years of professional work experience in clinical inspection, knowledge of GSP and ISO 13485, and proficiency in English reading and writing.

This is an office-based role with standard Monday-Friday hours and office environmental conditions.

This information is not specified in the job description.

Key duties include leading quality operations and managing nonconforming products, monitoring incoming inspections, coordinating with third-party warehouses, supporting post-market surveillance like complaints and investigations, prioritizing medical device recalls, implementing risk consultations, and reporting adverse events.

A strong candidate will have over 3 years of clinical inspection experience, relevant degrees in medical or biotech fields, required licenses, knowledge of GSP and ISO 13485 standards, and English proficiency to handle quality control, inspections, and post-market activities effectively.