Quality Engineer Iii

813

Plymouth, MN, United States
$93,225 - $136,730; not specified; comprehensive b...
Quality management systems (qms)
Fda regulations
Device history records (dhr)
Support the product development projects including phase 3, 4, and 5 quality deliverables, adhering to all safety and quality requirements

Job Summary

  • Support the product development projects including phase 3, 4, and 5 quality deliverables, adhering to all safety and quality requirements.
  • Leads and implements various product and process improvement methodologies, reviews changes to BOMs, Assembly Procedures, Drawings, and FMEAs.
  • Acts as a lead in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, and root cause analysis.

Matching Summary

Support the product development projects including phase 3, 4, and 5 quality deliverables, adhering to all safety and quality requirements.

Salary

$93,225 - $136,730; Not specified; Comprehensive benefits package

Skills & Requirements

Must-have

  • Quality Management Systems (QMS)
  • FDA regulations
  • Device History Records (DHR)
  • product and process improvement
  • risk analysis
  • test method validations
  • non-conforming materials

Nice-to-have

  • customer success focus
  • innovation and collaboration
  • respectful interaction
  • open and honest communication
  • integrity in actions

Key Requirements

  • Bachelor’s Degree in Engineering
  • 5-7 years' experience in medical device
  • Proficient in Microsoft Office and Minitab
  • Certified Quality Engineering (CQE) desired
  • Six Sigma Green Belt or Black Belt desired

Work Rights

Not specified

Tailored Resume

Cover Letter