KH
Senior Supplier Quality Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Senior
1 month ago
- CAPA
- Regulatory Compliance
1 month ago
Not enough detail in this posting to match
- 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.
Senior Supplier Quality Engineer · Katalyst Healthcares & Life Sciences