Not specified (potentially hybrid or onsite based on job requirements).
5+ years medical device experience
Expert knowledge of cgmp regulations
Strong experience with iq/oq/pq protocols
Thermo Fisher Scientific is seeking a Quality Engineer with expertise in QA Validation to lead validation activities in a GMP environment. The ideal candidate will possess significant medical device experience and a strong understanding of regulatory requirements, contributing to the development and manufacturing of critical healthcare solutions
Job Summary
Join the QA Validation team to contribute to global healthcare and scientific advancement by developing solutions for world challenges.
You will lead validation activities for critical systems and equipment while ensuring compliance with regulatory requirements and corporate standards.
The role offers opportunities to mentor staff and work on diverse projects ranging from new product introductions to complex system validations.
Matching Summary
Match Score: 85
Thermo Fisher Scientific is seeking a Quality Engineer with expertise in QA Validation to lead validation activities in a GMP environment. The ideal candidate will possess significant medical device experience and a strong understanding of regulatory requirements, contributing to the development and manufacturing of critical healthcare solutions.
Skills & Requirements
Must-have
5+ years medical device experience
Expert knowledge of cGMP regulations
Strong experience with IQ/OQ/PQ protocols
Computerized system validation expertise
Data integrity requirements knowledge
Manufacturing equipment qualification experience
Nice-to-have
Mentoring team members
Cross-functional collaboration skills
Project management leadership
Technical writing excellence
Audit and investigation support
Key Requirements
Bachelor's Degree plus 8 years experience OR Advanced Degree plus 6 years
Engineering, Science, or Biotechnology field of study
Experience in pharmaceutical/biotech manufacturing GMP environment