Senior Supplier Quality Engineer

Katalyst-Healthcares-; San Diego (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC in San Diego, CA, seeks an experienced Injection Molding Process Engineer to develop and qualify molding processes and production cells, lead mold design reviews, and collaborate with suppliers.

The role centers on process qualification, defect troubleshooting, CAPA, NPI and sustaining programs, with emphasis on FDA/ISO 13485 compliance and continuous improvement. 9+ years medical device experience and a Bachelor's in Engineering are preferred.

Qualifications

• Minimum 9+ years in a medical device environment with injection molding experience.
• Experience with large/complex plastic injection molding parts and qualification.
• Ability to lead mold design reviews and tooling development.
• Strong knowledge of IQ/OQ/PQ and process validation.

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 with molding suppliers on quality and process capability.
• Support supplier qualification, NPI and sustaining programs.
• Drive continuous improvement and ensure regulatory compliance.

Skills

Medical device experience

Mold process qualification

CAPA/SCAR

Root Cause Analysis

Process capability

Supplier quality

Regulatory compliance

Troubleshooting

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.