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Thermo Fisher Scientific Operational Quality Engineer in Rochester, New York

Job Description

Job Summary

Under the direction of the Manager, Quality Assurance Engineering and Quality Control, the Operational Quality Engineer is responsible for assuring manufacturing processes are in compliance with Thermo Fisher Scientific ISO/cGMP Quality Management System to produce consistent quality product. The Operational Quality Engineer will work in a fast-paced production environment to identify opportunities, support improvements, and reduce variation in our manufacturing processes resulting in improved product quality, delivery, and productivity.

Essential Functions

  • Manage all aspects of manufacturing quality including Non-Conforming Material Reports (NCM), Customer Complaint, Deviations and Audit Observations to ensure appropriate containment, disposition, and root cause investigations are completed in accordance with our ISO/cGMP QMS procedures

  • Review available information and data to complete impact assessment

  • Facilitate CAPA investigations with cross functional teams using problem solving tools to identify root cause and implement corrective actions to prevent reoccurrence

  • Ensure investigations and material dispositions are completed appropriately to close records in a timely manner

  • Proactively manage Corrective Actions (CAPAs) to ensure they are implemented within defined timeframes Develop and execute Effectiveness Checks to ensure corrective actions are effective Leverage Quality Assurance Engineering tools to identify opportunities through trending and analysis of data to develop and implement proactive solutions Provide support to Quality Controls Inspectors by ensuring appropriate QC Inspection Plans, standards, and inspection methods are in place and executed appropriately. Active member of Value Stream team through daily interaction with Manufacturing and regular participation in Tier Meetings; reporting value added data and identifying and owning actions to drive achievement of site goals Participate in PPI (Practical Process Improvement) and projects to support achievement of key process indicators (customer complaints, schedule accomplishment, back order, scrap, productivity, etc). Performs other duties as needed.

Skills and Abilities

  • Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision making, and ambition.

  • Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment.

  • Strong communication skills both written and verbal


  • Position requires a Bachelor’s of Science Degree in Engineering or equivalent experience, and 5 years Quality / Manufacturing or equivalent experience.

  • American Society of Quality (ASQ) Certified Quality Engineer (CQE) is desired

  • Disciplined problem solving capability: Lean / Six Sigma, Shainin, etc.

  • Experience in regulated medical device manufacture with compliance to FDA Quality System Regulation, EU Medical Device Directive and ISO 13485 is desired

  • Working knowledge of Excel, Word, Access, Minitab, quality software, and statistical methods (SPC, DOE, Gauge R&R etc.) and risk management techniques (dFMEA/pFMEA).

  • Prior experience using SAP Quality Module and TrackWise is desired

  • Plastic product manufacturing experience is desired

At Thermo Fisher Scientific, each one of our 70,000 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. When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in your career.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at for further assistance.

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.