Senior Supplier Quality Engineer

Katalyst CRO; Lincoln (NE); On-site; USD 80,000 - 110,000; Full time

Job summary

Katalyst CRO in Lincoln, NE seeks an experienced Injection Molding Engineer to develop and qualify molding processes and production cells. You will lead mold design reviews, drive supplier tooling development, and qualify new molds for production, ensuring robust process capability.

You will troubleshoot molding defects, drive RCA/CAPA activities, support NPI and sustaining programs, and maintain FDA and ISO 13485 environment compliance through continuous improvement.

Qualifications

• 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.

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.

Skills

Injection molding

Process qualification

CAPA / RCA

Root cause analysis

Supplier quality

NPI

Regulatory compliance

Mold design reviews

IQ / OQ / PQ

FDA & ISO 13485 familiarity

Education

Bachelor's Degree in Engineering or Related Field

Job description

• 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.

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.