Sr. Supplier Quality Engineer

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).

• 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.
  

• 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.
  

• 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.
  

• 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.
  

• 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.
  

• 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.
  

• Bachelors Degree in Engineering required.
  

• 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
    

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

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

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