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.
DESCRIPTION
The Engineer, Supplier Quality II supports Supplier Quality operations for manufacturing sites and business units by partnering with Procurement, Quality, Operations, Engineering, and suppliers to resolve supplier quality issues, support supplier evaluations, and maintain compliant supplier quality records. The role applies quality tools, supplier performance data, and risk-based thinking to improve supplier performance and protect product quality.
Supplier Evaluations and Qualification:
- Support and conduct supplier audits, desk audits, supplier evaluations, audit agendas, pre-meetings, and post-audit follow-up.
- Support NPI due diligence and supplier part qualification through PPAP requirements and supplier documentation review.
- Monitor supplier performance, communicate results, and drive actions to improve responsiveness and reduce risk.
Supplier Quality Issues:
- Engage suppliers on nonconformance, deviation, complaint, SCAR, and record-keeping activities.
- Support supplier problem-solving and root-cause analysis to eliminate recurrence of nonconformances.
- Facilitate resolution of supplier issues across suppliers, purchasing, manufacturing, Quality, and internal SMEs.
Documentation and Reports:
- Document procedures, audit reports, supplier change notifications, metrics, and supplier performance reports.
- Collect and analyze supplier scorecards and KPIs to support improvement actions.
- Support Quality Agreements and PPAP documentation for supplier qualification activities.
REQUIREMENTS
Education:
- 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.
Experience:
- Typical experience: 2-5 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.
Knowledge, Skills, and Abilities:
- 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.
Physical Requirements / Work Environment:
- 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.