Job Description A Senior Supplier Quality Engineer is responsible for ensuring that suppliers and externally sourced materials, components, and services consistently meet established quality, regulatory, and technical requirements. The role typically partners with suppliers, manufacturing, engineering, and quality teams to manage supplier performance, resolve quality issues, and drive continuous improvement.
9+ Years Medical Device Experience. Plastic Injection Molding - Large / Complex Parts. Injection Molding Process & Production Cell Qualification. Mold Design Reviews & Tooling Development. New Mold & Process Qualification. IQ / OQ / PQ & Process Validation. Injection Molding Defect Troubleshooting. Root Cause Analysis & Corrective Actions. CAPA / SCAR. Process Capability & Supplier Quality. Supplier Qualification / NPI / Sustaining Quality. FDA & ISO 13485 Environment. Bachelor's Degree in Engineering or Related Field. Develop and qualify injection molding processes and production cells. Lead mold design reviews and supplier tooling development. Qualify new molds and molding processes for production. Troubleshoot molding defects and drive RCA/CAPA activities. Partner directly with molding suppliers on quality and process capability. Support supplier qualification, NPI and sustaining programs. Drive continuous improvement and ensure regulatory compliance Show more Skills
Continuous Improvementunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
FDA (Food and Drug Administration)unmatched
ISO (International Organization for Standardization)unmatched
Identify Issuesunmatched
Injection Moldingunmatched
Machine Toolunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Medical Equipmentunmatched
Mold Designunmatched
Molding Processesunmatched
Performance Managementunmatched
Plastic Injection Moldingunmatched
Problem Solving Skillsunmatched
Process Capabilityunmatched
Process Improvementunmatched
Process Validationunmatched
Product/Service Launchunmatched
Quality Engineeringunmatched
Regulationsunmatched
Root Cause Analysisunmatched
Vendor/Supplier Evaluationunmatched
Vendor/Supplier Managementunmatched
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