Supplier Quality Engineer Ii

Edwards Lifesciences

United States
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Supplier corrective action reports
Notification of change projects
Supplier audits
** Edwards Lifesciences is seeking a Supplier Quality Engineer II to ensure compliance with quality engineering principles in the development and manufacturing of medical technology. The role involves leading investigations into manufacturing quality issues, managing supplier communications, and performing audits to uphold regulatory standards. **

Job Summary

  • Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
  • Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., SCARs (Supplier Corrective Action Reports), CAPAs, non-conformances, audit observations) for all production processes based on engineering principles.
  • Travel to perform Supplier Audits, act as Lead Auditor, and work with the supplier to perform proper root cause analysis to address audit findings using tools such as 5 Whys, DMAIC, PDCA, etc.

Matching Summary

Match Score: 75

** Edwards Lifesciences is seeking a Supplier Quality Engineer II to ensure compliance with quality engineering principles in the development and manufacturing of medical technology. The role involves leading investigations into manufacturing quality issues, managing supplier communications, and performing audits to uphold regulatory standards. **

Skills & Requirements

Must-have

  • Supplier Corrective Action Reports
  • Notification of Change projects
  • Supplier Audits
  • Root Cause Analysis
  • Product Risk Assessment
  • Manufacturing process controls knowledge

Nice-to-have

  • Highly regulated industry experience
  • Effective problem-solving techniques
  • In-depth knowledge of Quality Management Systems
  • Six Sigma concepts

Key Requirements

  • Bachelor's degree in Engineering or Scientific field with at least 2 years of experience
  • Master's degree in Engineering or Scientific field with no experience
  • Experience with supplier quality engineering activities
  • Ability to read and interpret drawings

Work Rights

Not specified

Tailored Resume

Cover Letter