Supplier Quality Engineer

• Ensure suppliers deliver quality parts, materials, and services in accordance with established company standards.
  
• Qualify and evaluate suppliers according to company requirements and applicable quality standards.
  
• Support and/or administer Certified Supplier Programs and receiving inspection activities to improve quality and cost effectiveness.
  
• Monitor purchased parts and components from acquisition through the manufacturing cycle.
  
• Identify, communicate, investigate, and support the resolution of supplier-related quality issues.
  
• Evaluate supplier operations and internal quality systems to assess overall performance and provide appropriate feedback.
  
• Partner with cross-functional teams, including R&D, Sourcing, Engineering, Operations, and Quality, to prevent defects and ensure the delivery of reliable, high-quality products.
  
• Provide technical guidance and quality compliance support throughout the product lifecycle, with particular focus on supplier-related changes.
  
• Implement strategies to improve supplier and product quality while supporting continuous improvement initiatives.
  
• Ensure purchased products and components are manufactured and qualified according to applicable industry standards, regulatory requirements, and customer requirements.
  
• Collaborate with cross-functional teams to develop and implement Product Acceptance Sampling Strategies, Approved Supplier List coordination, Supplier Owned Quality initiatives, and Control Plans for new products.
  
• Define Receiving Inspection requirements as needed.
  
• Support test method validation activities for applicable internal test methods.
  
• Perform other duties as assigned.
  
  

Requirements

• Bachelor’s degree in Engineering.
  
• Minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience.
  
• Demonstrated experience with Medical Device Industry or Automotive part qualification requirements.
  
• Advanced knowledge of supplier quality, quality systems, manufacturing processes, and component qualification.
  
• Knowledge of applicable regulatory and industry quality requirements.
  
• Strong analytical, problem-solving, communication, and cross-functional collaboration skills.
  
• Practical knowledge of project management is preferred.
  

• Knowledge of ISO 13485 requirements.
  
• Knowledge of FDA Quality Management System Regulation (QMSR) requirements.
  
• Knowledge of Geometric Dimensioning and Tolerancing (GD&T).
  
• Experience with supplier and/or component qualification activities.
  
• Experience with receiving inspection requirements and test method validation.
  
• Experience using Agile is a plus.
  
• Experience using TrackWise is a plus.