Thermo Fisher Scientific Supplier Quality Engineer in Rochester, New York

Job Description

Key Responsibilities:

  • Leads and manages the execution of objectives for the control of external suppliers, contract manufacturers and service providers in alignment with corporate goals and objectives; including assuring the supply of on-time, acceptable product and services

  • Drives continuous improvement with procedures, policies and quality assurance methodologies including but not exclusive to: new material qualification, end of life materials/components, product development process, supplier requests for material changes and sustaining engineering

  • Collaborates with Procurement, R&D and Operations to effectively define roles and responsibilities and supply priorities and actions

  • Ensures the Supplier Quality function operates according to procedures and provides direction to other departments. Is a champion of problem solving and root cause analysis activities with suppliers and customers to eliminate recurrence of non‐conformances

  • Collaborates with the Procurement team assigned to support supplied products and materials. Develops long‐term supplier relationships, generates and implements cost reduction ideas. Aligns with Purchasing to report supplier performance while monitoring ratings and uncooperative suppliers

  • Review and approves supplier records including but not exclusive to: contracts, quality plans, change requests, SCARs/CAPAs, NCRs, verification and validation protocols and reports.

  • Perform External Supplier Audits in the region and develop and manage the Rochester NY Sites' external supplier audit schedules.

  • Manages the Supplier Review Board meetings and other critical decision-making meetings as required to define Suppliers roles, responsibilities and effectiveness

People Specification:

  • B.S. Engineering/Operations Management, Biological Sciences or equivalent

  • 3-5 years experience in Supplier Quality

  • Solid experience with IS0 13485 or IS0 9001 and/or 21 CFR Part 820- or other regulated industry

  • Excellent oral and written communication skills

  • Fluent in English

  • 5 years experience as a lead auditor training and certification preferred

  • Lean Six Sigma Green or Black Belt certified highly preferred

  • International travel/foreign business exposure a Plus

  • 20%-40% Travel (US & Canada)

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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.