Thermo Fisher Scientific Supplier Quality Engineer in Tewksbury, Massachusetts

Job Description

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 achieving your career goals.

This position is located in Tewksbury, MA

How will you make an impact?

You will support the processes for qualifying new suppliers, analyze and improve supplier performance, implement corrective actions or quality plans internally as well as at the supplier to prevent repeat non-conformances using Quality Tools (FMEA, CpK, SPC, etc.) and perform supplier audits. The Supplier Quality Engineer develops and updates procedures & processes in compliance with ISO 9001:2015 and other external requirements. Actively participates in strategic supplier development based on quality control plans.

What will you do?

  • Maintain and report meaningful supplier performance metrics to demonstrate the effectiveness of the supplier quality process and advising management of potential risks and make recommendations.

  • Work closely with the Purchasing Team to select, qualify and develop suppliers by performing initial and periodic follow-up assessments/audits and assess suppliers against robust qualification requirements.

  • 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.

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

  • Act as an Auditor during supplier audits. Ensure management of supplier audits from planning to completion.

  • Work with Incoming Inspection to refine FAI (First Article Inspection) Process, ensuring compliance to TFS requirements.

  • Participate in and create necessary design changes related to supplier provided materials.

  • 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.

  • Support the suppliers to ensure that products and processes comply with the relevant requirement.

  • Support Quality Management Team in establishing, implementing, and maintaining the quality management system for ISO 9001:2015.

  • Assists in the development of procedures & processes in compliance with ISO & other external requirements

  • Travel is required – approximately 10-20% depending on status of suppliers and supplier issues.

  • Thorough understanding of ISO/QSRs and the ability to apply the knowledge to the business to ensure compliance to the regulations.

  • Aware of and comply with TFS and associated Quality Manuals, regulatory requirements and most current world class best practices for the effective management and continuous improvement of supplier quality.

  • Participate in PPI (Practical Process Improvement) and projects to support achievement of business metrics to drive improvement to the quality of our products and processes

How will you get here?

  • B.S. Engineering (Mechanical or Optical)

  • Minimum 3 years’ experience in Supplier Quality and Quality Management.

  • Ability to focus on continual improvement practices using causal analysis tools to drive corrective and preventive actions.

  • Must be able to read and interpret engineering drawings.

  • Software Validation Experience preferred

  • Electro Mechanical Test Development Experience required

  • ISO auditor training and certification a plus

  • Effective problem solving, root cause analytical skills to lead and influence others to drive change (cross-functionally and globally)

  • ASQ Certified Quality Engineer preferred

Field and Safety Instruments (FSI) is a new business within Thermo Fisher that was established in 2017 by the merger of two legacy businesses. FSI is the leader in handheld spectrometers for a wide range of applications across industrial, pharma, safety/security, nuclear power, and healthcare markets. We are in search of a product manager for one of our leading spectroscopy product lines. The ideal candidate will have had experience as a product manager or marketing manager in a B2B environment.

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.

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.