Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION
The Engineer, Supplier Quality III leads defined Supplier Quality activities for manufacturing sites and business units, including supplier issue management, supplier qualification support, PPAP/part qualification, audit prioritization, and supplier performance improvement. The role collaborates across functions and with suppliers to drive root-cause resolution, risk mitigation, and sustained reduction of supplier nonconformances.
Supplier Evaluations and Qualification
- Determine audit prioritization based on supplier risk and performance, and communicate results to suppliers and stakeholders.
- Lead supplier evaluation activities, NPI supplier due diligence, and PPAP/part qualification execution.
- Collaborate with Procurement, Quality, Operations, and Engineering to define actions and priorities for supplier quality issues.
Supplier Quality Issues
- Establish and oversee processes for issue reporting, nonconformance, deviation, SCAR, and complaint management.
- Manage supplier corrective and preventive actions and drive root-cause analysis to eliminate recurrence.
- Act as supplier liaison for escalation of inspection and testing issues, ensuring product control procedures are followed.
Documentation and Reports
- Oversee documentation compliance, review records for completeness and validity, and approve updated documentation as appropriate.
- Create and execute Quality Agreements and PPAP documentation supporting supplier qualification.
- Use PPI and data analysis to correct performance gaps and improve supplier quality processes.
REQUIREMENTS
- Bachelor's degree in Engineering, Manufacturing, Operations Management, Biological Sciences, Chemistry, Business, or equivalent combination of education and experience required for professional, management, and leadership roles; associate degree or equivalent technical experience may be acceptable for associate roles.
- Quality auditor training preferred for bands 4-6; quality lead auditor training preferred or required for advanced professional roles depending on business need.
- Supplier audit, supplier qualification, PPAP/part qualification, supplier issue management, and corrective action experience preferred.
- Typical experience: 5-8 years in Supplier Quality, Quality, Manufacturing, Operations, Engineering, Business Process, or related functions.
- Equivalent combinations of education, experience, and demonstrated capability may be considered based on business needs.
- Working knowledge of ISO 9001 and applicable industry standards; experience with ISO 13485, 21 CFR Part 820, 21 CFR Part 210/211, ISO 14971, MDSAP, or other applicable requirements preferred based on business context.
- Strong written and oral communication skills with the ability to collaborate across functions and build effective relationships with suppliers, internal customers, and stakeholders.
- Ability to analyze data, summarize results, generate metrics, identify risks, and drive improvement actions.
- Detail-oriented, organized, accurate, self-motivated, adaptable, and able to prioritize work to meet business objectives.
- May sit or stand for long periods and walk between buildings or to production, laboratory, warehouse, or office areas.
- Close vision is needed to read documents, quality records, and computer screens.
- May lift up to 15-20 lbs. as business needs require.
- Travel by air, train, or car may be required; supplier-facing and leadership roles may require up to approximately 30% travel depending on business needs.