Quality Engineer Iii

Integer

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 and adhere to all safety and quality requirements

Job Summary

  • Support the product development projects including phase 3, 4, and 5 quality deliverables and adhere to all safety and quality requirements.
  • Lead and implement various product and process improvement methodologies, review changes to BOMs, Assembly Procedures, Drawings, and FMEAs.
  • The total rewards program includes base salary, cash-based incentive program, comprehensive benefits with immediate eligibility, 401(k) with company match, holidays, and paid time off.

Matching Summary

Support the product development projects including phase 3, 4, and 5 quality deliverables and adhere 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 company matching

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
  • CAPA activities

Nice-to-have

  • customer success focus
  • innovative solutions
  • collaborative team environment
  • respectful interactions
  • 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
  • Competence in Quality Engineering Tools and Techniques
  • Knowledge of relevant Regulations and Industry Standards (ISO, QSR, UL, MDD, TGA)
  • Proficient in Microsoft Office and Minitab

Work Rights

Not specified

Tailored Resume

Cover Letter