Senior Supplier Quality Engineer

Katalyst HealthCares and Life Sciences

• $95K — $115K *
Lincoln, NE 68516In-Person
Healthcare
8 - 10 years of experience
Yesterday
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • 9+ years experience in the medical device industry
  • Expertise in plastic injection molding of large and complex parts
  • Proficient in process and production cell qualification
  • Experience in mold design reviews and tooling development
  • Skilled in new mold and process qualification
  • Familiar with process validation (IQ/OQ/PQ)
  • Strong abilities in troubleshooting injection molding defects

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 root cause analysis and corrective action initiatives
  • Partner with molding suppliers to ensure quality and process capability
  • Support supplier qualification, new product introduction, and sustaining programs
  • Drive continuous improvement initiatives and ensure compliance with regulations

Benefits

  • Opportunities for professional growth and development
  • Collaboration with industry-leading experts
  • Access to cutting-edge technology and processes
  • Commitment to quality and regulatory excellence
  • Engagement in continuous improvement and compliance efforts
Full 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.
* Ladders Estimates

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