Senior Supplier Quality Engineer
Job in
Lincoln, Lancaster County, Nebraska, 68501, USA
Listed on 2026-09-01
Listing for:
Katalyst Healthcares & Life Sciences
Full Time
position Listed on 2026-09-01
Job specializations:
-
Engineering
Quality Engineering, Process Engineer, Manufacturing Engineer, Injection Molding
Job Description & How to Apply Below
Job Title
Roles and 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.
Position Requirements
10+ Years
work experience
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