Job Title: Quality Engineer II - Quality Assurance
Requisition ID: 64049BR
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.
- Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of process and product.
- Leading quality activities to assure the product meets internal and external requirements.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Leads and implement various product and process improvement methodologies (e.g., PPI, Kaizen Events,).
- Oversees the investigation, resolution and prevention of product and process non-conformances.
- Promote implementation of manufacturing controls by developing and facilitating use of standardized batch record templates.
- Perform document review/approval on all new/revised batch records.
- Ensure that developed procedures and specifications are appropriate and followed.
- Archive, store and maintain all document files to comply with Corporate and Site policies in a state of audit readiness.
- Perform production Batch Record Review, product release, and investigate discrepancies.
- Work cross departmentally to address quality issues.
- Monitor and report associated quality metrics and recommend improvements.
- Perform other duties as may be required or necessary.
- B.S. degree in Engineering, Technical or related field
- 2-5 years of experience in a Quality role.
- Experience with Quality tools/methodologies.
- Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
- Solid communication and interpersonal skills.
- Project management and leadership skills, including the demonstrated ability to resolve quality-related issues in a timely and effective manner.
- Advanced computer skills, including statistical/data analysis, SAP, Oracle E1, TrackWise, and report writing skills is preferred.
- Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
- Good organization and multi-tasking skills and drive for results and making sound business decisions.
- Strong knowledge of using Microsoft Excel and Word required
- Working conditions:
- Works primarily in an office environment, but may also require time in laboratory/manufacturing environments.
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.