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Senior Supplier Quality Engineer

PublishedPublished: 6/14/2022
Manufacturing

Job Description

Job DescriptionRoles & 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.
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