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Katalyst Healthcares & Life Sciences

Senior Supplier Quality Engineer

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What they do

A Supplier Quality Engineer manages relationships with suppliers with a focus on improvement of product quality. Performs audits to ensure compliance with quality standards of their organization and regulatory standards.

$97,143 / year median in Nebraska

-3% projected decline

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Job Description

Senior Supplier Quality Engineer Katalyst Healthcares & Life Sciences - 4.0 Lincoln, NE Job Details Contract 21 hours ago Qualifications Defect resolution root cause analysis Supplier corrective action implementation Preventive action implementation Design of manufacturing processes Tooling design Production deviation management Engineering process optimization Injection (injection molding) Quality control preventive actions Corrective and preventive actions (CAPA) Production validation processes Medical device manufacturing facility experience Supplier development Design engineering Regulatory/legal compliance standards in production Biomedical regulatory compliance Quality improvement programs in engineering Legal compliance Product quality failure
ISO 13485 FDA
regulations Failure analysis
Full Job Description 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+ Yea rs 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.