About The Position

Support the Supplier and Distribution Quality organization by identifying, evaluating, and establishing the Approved Supplier List (ASL) for distributors and Third-Party Logistics providers (3PLs). Support development and negotiation of Quality Agreements with suppliers, distributors, and 3PLs. Monitor supplier quality and performance and ensure suppliers deliver quality parts, materials, and services in accordance with company requirements. Qualify suppliers according to company standards and support 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, including managing them through the Supplier CAPA process. Develop, prioritize, and execute supplier audit schedules; conduct audits to verify compliance with GMP and applicable quality standards; and evaluate suppliers’ internal processes, quality systems, and overall performance. Provide feedback and recommendations based on supplier assessments and audit results. Collaborate with Distribution teams to select and qualify new distributors and 3PLs. Support supplier validation and qualification activities, define Receiving Inspection requirements as applicable, and 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

  • Bachelor’s degree in Engineering and a minimum of 4 years of relevant experience, or an advanced degree and a minimum of 2 years of relevant experience.

Nice To Haves

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

Responsibilities

  • Identify, evaluate, and establish the Approved Supplier List for distributors and 3PLs.
  • Support development and negotiation of Quality Agreements with suppliers, distributors, and 3PLs.
  • Monitor and evaluate supplier quality and performance, ensuring supplied parts, materials, and services meet company requirements.
  • Qualify suppliers according to company standards.
  • Support or administer Certified Supplier Programs and Receiving Inspection activities.
  • Monitor parts and materials throughout the acquisition and manufacturing lifecycle.
  • Identify, communicate, investigate, and resolve supplier-related quality issues; manage 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 assessments and audit results.
  • Collaborate with Distribution teams to select and qualify new distributors and 3PLs.
  • Support supplier validation and qualification activities.
  • Define Receiving Inspection requirements, as applicable, and support related Test Method Validation activities.
  • May provide Pre-Market Supplier Quality Engineering support for New Product Development.
  • Partner cross-functionally to prevent defects and ensure product quality and reliability.
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