Senior Supplier Quality Engineer

Katalyst Healthcares & Life Sciences

Davey, NE

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.

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Vacancy posted 2 days ago

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