Katalyst CRO

Validation Engineer NPI

Irving, TX, US

about 1 month ago
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Summary

Roles And Responsibilities

  • NPI Validation, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), pFMEA and dFMEA.
  • 3+ years of experience & demonstrated proficiency in New Product Introduction, Windchill PLM & providing ongoing technical support is preferred.
  • Under limited supervision, performs and documents moderately complex technical functions relating to test, quality control, Client-out, fabrication, modification, and assembly of mechanical or electrical equipment and/or components.
  • Experience in validation of product and equipment.
  • Experience in New Product Introduction (NPD) with Solidworks.
  • Knowledge of good manufacturing practices and documentation, preferably in the medical industry.
  • Risk management experience pFMEA and dFMEA.
  • Knowledge on QMS - NC, CAPA and contribution in audits and ETQ instinct experience if any.
  • Preferably with knowledge of ISO 13485, FDA 21 CFR Part 820 and GMP.
  • JnJ experience with ADAPTIV and Windchill PLM.
  • Oral and written communication in English.

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