Sr. Supplier Quality Engineer

Summary

The Senior Supplier Quality Engineer supports the Supplier and Distribution Quality organization by managing supplier quality activities, ensuring compliance with quality standards, and maintaining approved supplier relationships. This role is responsible for supplier qualification, auditing, performance monitoring, supplier CAPA management, and supporting validation and qualification activities with suppliers, distributors, and third-party logistics providers (3PLs).

Key Responsibilities

Supplier Quality Management

• Identify, evaluate, and establish Approved Supplier Lists (ASL) for distributors and third-party logistics providers (3PLs).
  
• Negotiate and maintain Quality Agreements with suppliers, distributors, and 3PL partners.
  
• Monitor supplier performance and implement continuous improvement initiatives.
  
• Ensure suppliers consistently deliver quality parts, materials, and services.
  

Supplier Qualification & Compliance

• Qualify suppliers according to company standards and quality requirements.
  
• Support and administer Certified Supplier Programs.
  
• Participate in receiving inspection programs to ensure supplier effectiveness.
  
• Define receiving inspection requirements and associated test method validations.
  

Supplier Auditing & Performance Assessment

• Develop and execute supplier audit schedules.
  
• Conduct supplier audits to ensure compliance with:
  
  • Good Manufacturing Practices (GMP)
    
  • Quality System Requirements
    
  • Regulatory Standards
    
• Evaluate suppliers’ internal functions and overall performance.
  
• Provide feedback and assessments to support supplier development and improvement.
  

Supplier Issue Resolution & CAPA

• Monitor purchased parts throughout the manufacturing lifecycle.
  
• Investigate supplier-related quality issues.
  
• Lead and support Supplier Corrective and Preventive Action (CAPA) activities.
  
• Collaborate with cross-functional teams to resolve supplier quality concerns.
  

New Product Development (NPD) Support

• Provide Supplier Quality Engineering support for New Product Development projects.
  
• Partner with:
  
  • Component Engineering
    
  • Post-Market Supplier Quality
    
  • Distribution Quality Teams
    
• Ensure suppliers provide quality materials, components, and services for new product launches.
  
• Support risk mitigation efforts to prevent quality defects and improve product reliability.
  

Distribution & 3PL Support

• Collaborate with Distribution teams in the selection and qualification of:
  
  • New Distributors
    
  • Third-Party Logistics Providers (3PLs)
    
• Support validation and qualification activities related to distribution networks.
  

Requirements

Education

• Bachelor's Degree in Engineering required.
  

Experience

• Minimum 4 years of relevant Supplier Quality Engineering experience.
  
• Candidates with an advanced degree require a minimum of 2 years of relevant experience.
  
• Experience working with:
  • Distribution Centers
    
  • 3PL Suppliers
    
  • Supplier Quality Systems
    

Technical Knowledge

• Supplier Qualification Processes
  
• Supplier Auditing
  
• Supplier CAPA Management
  
• GMP Compliance
  
• Quality Systems
  
• Receiving Inspection Programs
  
• Validation and Qualification Activities
  
• Quality Agreement Management
  

Preferred Qualifications

Certifications

• ISO 13485 Lead Auditor Certification
  
• ASQ Certified Quality Engineer (CQE)
  
• Six Sigma Certification (Green Belt, Black Belt, or equivalent)
  
• Other Continuous Improvement Certifications
  

Additional Skills

• Experience leading projects.
  
• Experience with SAP.
  
• Experience working in Agile environments.
  
• Experience with TrackWise.