Quality Engineer Iii

985fm.ca

Plymouth, MN, United States
Base: $93,225 - $136,730; bonus/equity: cash-based...
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, including risk analysis and test method validation protocols.
  • Works with suppliers, management, and manufacturing associates to resolve quality problems and apply statistical quality control techniques.

Matching Summary

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

Salary

Base: $93,225 - $136,730; Bonus/Equity: cash-based incentive program; Benefits: medical, dental, vision, disability, life insurance, adoption benefits, 401(k) with match, paid time off, holidays

Skills & Requirements

Must-have

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

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 or related field
  • 5-7 years’ experience in medical device or regulated manufacturing
  • Proficient in Microsoft Office and Minitab
  • Knowledge of SPC, FMEA, DOE, RCA, GDT
  • Sound knowledge of quality management systems

Work Rights

Not specified

Tailored Resume

Cover Letter