Senior Supplier Quality Engineer

Katalyst CRO; San Diego (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Katalyst CRO in San Diego, CA seeks an experienced Injection Molding Engineer to develop and qualify molding processes and production cells for medical devices. You will lead mold design reviews, work with suppliers on tooling development, and qualify new molds for production to ensure high quality, reproducibility, and regulatory compliance.

This role requires extensive experience with large/complex plastic parts, IQ/OQ/PQ, CAPA/SCAR, and strong problem-solving skills to drive continuous

Qualifications

• 9+ years of 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

Mold design reviews

Process validation

CAPA/SCAR

Root cause analysis

NPI & sustaining quality

Regulatory compliance (FDA ISO 13485)

Supplier qualification

Troubleshooting defects

Production cell qualification

Cross-functional collaboration

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+ 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.