Senior Supplier Quality Engineer

Creative Solutions Services, LLC; Lincoln (NE); On-site; USD 95,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a seasoned engineer to lead the development and qualification of large-part plastic injection molding processes. You will drive mold design reviews, tooling development, and process validations in a regulated medical device environment, ensuring quality and compliance with FDA and ISO 13485 requirements.

This role partners with suppliers, leads CAPA activities, and champions continuous improvement.

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

9+ Years Medical Device Experience

Root Cause Analysis

CAPA / SCAR

Process Validation

Supplier Quality

NPI / Sustaining Quality

FDA & ISO 13485 Environment

Education

Bachelor's Degree in Engineering or Related Field

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.