Senior Supplier Quality Engineer

• Support the Supplier and Distribution Quality organization.
  
• Identify, evaluate, and establish the Approved Supplier List (ASL) for distributors and Third-Party Logistics providers (3PLs).
  
• Support the development and negotiation of Quality Agreements with suppliers, distributors, and 3PLs.
  
• Monitor and evaluate supplier quality and performance.
  
• Ensure suppliers deliver quality parts, materials, and services in accordance with company requirements.
  
• Qualify suppliers according to company standards.
  
• Support and/or administer Certified Supplier Programs and Receiving Inspection activities to improve quality and cost effectiveness.
  
• Monitor parts and materials throughout the acquisition and manufacturing lifecycle.
  
• Identify, communicate, investigate, and resolve supplier-related quality issues.
  
• Manage supplier-related issues through the Supplier CAPA process.
  
• Develop, prioritize, and execute supplier audit schedules.
  
• Conduct supplier audits to verify compliance with GMP and applicable quality standards.
  
• Evaluate suppliers' internal processes, quality systems, and overall performance.
  
• Provide feedback and recommendations based on supplier assessments and audit results.
  
• Collaborate with Distribution teams in the selection and qualification of new Distributors and 3PLs.
  
• Support supplier validation and qualification activities.
  
• Define Receiving Inspection requirements, as applicable.
  
• Support associated Test Method Validation (TMV) activities.
  
• May provide Pre-Market Supplier Quality Engineering support for New Product Development (NPD).
  
• Partner cross-functionally with Component Engineering, Post-Market Supplier Quality, Distribution, Quality, and other functional teams to prevent defects and ensure product quality and reliability.
  

Requirements

Required Qualifications

• Bachelor’s Degree in Engineering.
  
• Minimum of 4 years of relevant experience, OR
  
• Advanced degree with a minimum of 2 years of relevant experience.
  

Preferred / Nice-to-Have Qualifications

• Experience working with Distribution Centers and 3PL suppliers.
  
• Experience with supplier qualification, supplier audits, Supplier CAPA, and supplier performance monitoring.
  
• ISO 13485 Lead Auditor Certification.
  
• ASQ Certified Quality Engineer (CQE) certification.
  
• Six Sigma or other Continuous Improvement methodology certification.
  
• Experience leading projects.
  

Technical Skills

• Experience with SAP desired.
  
• Experience with Agile desired.
  
• Experience with TrackWise desired.