Quality Engineer Ii Orthopedics ( 2nd Shift)

Johnson & Johnson

Juarez, Chihuahua, Mexico
Process validation and control
Risk management
Statistical analysis
Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management

Job Summary

  • Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management.
  • Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes and control plans consistent with product classification.
  • Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.

Matching Summary

Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management.

Skills & Requirements

Must-have

  • process validation and control
  • risk management
  • statistical analysis
  • manufacturing processes
  • sampling plans
  • process monitoring and control

Nice-to-have

  • stakeholder analysis
  • design controls
  • new product introduction
  • hands-on troubleshooting
  • cross-functional partners

Key Requirements

  • 2-4 years related experience
  • Bachelor’s Degree
  • FDA and European regulatory environment experience
  • Risk mitigation implementation experience
  • Statistics, Lean and Six Sigma Methodologies experience
  • Statistical software packages knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter