Job Title: Engineer II, QA/QC
Requisition ID: 56609BR
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
- Developing, implementing and validating process methodology to ISO 13485, 9001 and FDA standards. Setup, revising and updating Standard Operating Procedures, system or processes.
- Constantly review procedures and processes and work closely with key internal partners to provide recommendations for improvements. Develop procedures, work instructions, guidance, best practice protocol.
- Ensure that the lab, manufacturing and development processes are compliant with Quality System and EHS requirements.
- Assignments include areas such as leading product transfer, troubleshooting, non-conformance evaluation, customer complaint handling investigations, CAPA, process & system enhancement and drive sustaining activities to meet QA goals, etc
- Work in accordance with procedures and integrated program plans for achieving and maintaining the required level of product quality in preparation for FDA and ISO audits (internal, customer and registrar audits).
- Works on problems of diverse scope where analysis of data requires review and interpretation of identifiable factors. Demonstrates solid judgment in selecting methods and techniques for obtaining solutions.
- Establishes working relationships across functions. Employs internal working relationships to influence business objectives.
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
- Bachelor’s degree in Engineering or Biological/Life Sciences.
- >3 years of experience in quality management, and/or quality departments within an IVD regulated environment, preferred
This position does not have relocation assistance
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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