Engineer, Supplier Quality II

• Support Supplier Quality operations for manufacturing sites and business units
• Partner with Procurement, Quality, Operations, Engineering, and suppliers to resolve supplier quality issues
• Support supplier evaluations and maintain compliant supplier quality records
• Apply quality tools, supplier performance data, and risk-based thinking to improve supplier performance and protect product quality
• 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
• 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 subject-matter experts
• 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

• 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
• 2–5 years of experience 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
• 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
• Ability to sit or stand for long periods and walk between buildings or to production, laboratory, warehouse, or office areas
• Close vision needed to read documents, quality records, and computer screens
• May lift up to 15–20 lbs. as business needs require
• Ability to travel by air, train, or car as required; supplier-facing and leadership roles may require up to approximately 30% travel
• Adherence to all Good Manufacturing Practices (GMP) safety standards

• Fully remote work arrangement
• Standard Monday–Friday work schedule
• Global work with Thermo Fisher Scientific
• Potential professional development through quality auditor and lead auditor training, where applicable