Senior Supplier Quality Engineer
About The Position
Support the Supplier and Distribution Quality organization by qualifying and monitoring suppliers, distributors, and Third-Party Logistics providers (3PLs). The role helps ensure that suppliers provide quality parts, materials, and services in accordance with company requirements, and supports supplier quality activities across the acquisition and manufacturing lifecycle. Responsibilities include establishing and maintaining the Approved Supplier List, supporting Quality Agreements, administering supplier programs and receiving inspection activities, and identifying and resolving supplier-related quality issues through the Supplier CAPA process. The position also develops and conducts supplier audits, supports supplier validation and qualification, defines receiving inspection requirements, and may provide Pre-Market Supplier Quality Engineering support for New Product Development. The role partners 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.
- Minimum of 4 years of relevant experience, or an advanced degree with 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 desired.
- Experience with Agile desired.
- Experience with TrackWise desired.
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
