Senior Supplier Quality Engineer
Katalyst HealthCares & Life Sciences
Job-ID Reference Roles & Responsibilities: 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.Requirements: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.
Vacancy posted 3 days ago
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