Senior NPI Quality Engineer

Irvine, CA, US • Posted 1 day ago • Updated 1 day ago
Contract W2
7 Months
On-site
Depends on Experience
Fitment

Dice Job Match Score™

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Job Details

Skills

  • NPI
  • Design Transfer
  • PFMEA
  • FMEA
  • ISO 14971
  • PPAP
  • FAI
  • IQ/OQ/PQ
  • Process Validation
  • Medical Devices
  • ISO 13485
  • CAPA
  • NCR.

Summary

  • 5+ years of Quality Engineering experience in the Medical Device industry
  • Strong experience with New Product Introduction (NPI) and Design Transfer
  • Hands-on experience with Risk Management (PFMEA/FMEA, ISO 14971)
  • Develop and improve inspection processes and support First Article Inspection (FAI)
  • Experience with Validation (IQ/OQ/PQ), PPAP, and Process Validation
  • Collaborate with R&D, Manufacturing, and Quality teams throughout the product lifecycle
  • Knowledge of ISO 13485, CAPA, NCR, and GMP is preferred

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 80168598
  • Position Id: 9043279
  • Posted 1 day ago
Contact the job poster
SP

Sandeep Puttaswamy

Recruiter @ Radiant System, Inc
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