Engineer Ii, Quality

Edwards Lifesciences

United States
Not specified
Manufacturing product quality and compliance
Manage site ncrs, capas, ecrs
Product release and mrb management
Edwards Lifesciences is seeking a Quality Engineer II to optimize product development and ensure compliance with regulatory requirements. The role involves investigating manufacturing product quality issues, managing non-conformance reports, and collaborating with engineering teams for process improvement

Job Summary

  • Our Quality Engineer II position is a unique career opportunity that could be your next step towards an exciting future.
  • Investigate moderately complex manufacturing product quality and compliance issues which may include: Investigate PRAs and complaints for manufacturing related issues.
  • Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma, TOPP and LEAN methods) for design for manufacturing and for continuous process improvement.

Matching Summary

Match Score: 85

Edwards Lifesciences is seeking a Quality Engineer II to optimize product development and ensure compliance with regulatory requirements. The role involves investigating manufacturing product quality issues, managing non-conformance reports, and collaborating with engineering teams for process improvement.

Skills & Requirements

Must-have

  • Manufacturing product quality and compliance
  • Manage site NCRs, CAPAs, ECRs
  • Product release and MRB management
  • Process optimization using engineering methods
  • Risk management files and pFMEAs
  • Support process validation

Nice-to-have

  • Good documentation and communication skills
  • Negotiating and relationship management skills
  • Team environment and stakeholder management
  • Build productive relationships

Key Requirements

  • Bachelor’s degree in Engineering or scientific field with 2 years experience
  • Master’s degree in Engineering or scientific field
  • 2 years related work experience

Work Rights

Not specified

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