Engineer I, QA

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and approximately 50,000 employees in 50 countries. 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 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 support.

All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.

Provide Quality Assurance Support to the Rockford site. Provide product and quality system information to internal and external customers. Review new paperwork and proposed changes for appropriateness and determine potential effects on product quality. Help strengthen our quality system and make improvements where needed. Help educate and promote adherence to Quality Assurance policies and requirements. Work with Quality Control in the review and development of specifications, test methods and protocols.

Key Responsibilities:

• Provide Quality Assurance Support to the Rockford site

• Complete Customer surveys and specification verifications
• Review and approve engineering change notices and deviations for appropriateness and to determine potential effect on product quality
• Assist with the maintenance of ISO registration and the internal audit program
• Investigate quality problems
• Perform and coordinate review of raw materials to determine continued suitability at retest/review dates
• Assists with creation/modification of Certificates of Analysis templates
• Assist Customer Service, Technical Support, Regulatory Affairs, and Analytical Services in addressing customer inquiries and concerns
• Process product integrity customer complaints
• Perform training on Quality procedures
• Gather and maintain Country of Origin and animal origin information
• Review and update standard operating procedures
• Perform and coordinate incoming inspection of purchased items as a back-up
• Collect and analyze quality data
• Participate, as needed, on new product teams
• Perform all job duties in a safe manner and obeys all safety policies and procedures
• Perform all job duties consistent with the Code of Ethics and the 4-I values
• Perform all job duties within ISO standards, regulatory or statutory requirements
• Perform other duties and cross training as assigned

Minimum Requirements/Qualifications:

• Bachelor’s degree required in a scientific discipline
• 1+ years related experience in a manufacturing or quality environment
• Strong written and oral communication skills
• Must be able to communicate effectively with multiple levels of staff throughout the organization
• Possess strong organizational skills with the ability to manage and prioritize multiple tasks and meet deadlines
• Detail-oriented and accurate while maintaining a vision of the result
• Employee must be self-motivated with the ability to work as a team player and/or independently

• Knowledge of ISO and cGMP requirements preferred
• Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors

This position has not been approved for Relocation Assistance.