Quality Engineer Ii

126

Base salary not specified; cash-based incentive pr...
Bachelor's degree in engineering
3 years relevant experience
Iso qsr fda regulations knowledge
The primary purpose of this position is to perform work involving general engineering methods while utilizing advanced quality tools in the medical device industry

Job Summary

  • The primary purpose of this position is to perform work involving general engineering methods while utilizing advanced quality tools in the medical device industry.
  • You will support regulatory and agency inspections, audits, and investigations regarding the control and assessment of product design and manufacturing quality.
  • The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with matching contributions.

Matching Summary

The primary purpose of this position is to perform work involving general engineering methods while utilizing advanced quality tools in the medical device industry.

Salary

Base salary not specified; Cash-based incentive program available; Comprehensive benefits package including medical, dental, vision, 401(k) match

Skills & Requirements

Must-have

  • Bachelor's degree in engineering
  • 3 years relevant experience
  • ISO QSR FDA regulations knowledge
  • Device History Records maintenance
  • FMEA and Control Plan review
  • Test method validation protocols
  • Non-conforming material disposition

Nice-to-have

  • Continuous improvement project leadership
  • Strong written and oral communication
  • Positive can-do attitude
  • Collaborative cross-functional teamwork
  • Data analysis for root cause identification
  • 5S workplace organization experience

Key Requirements

  • Bachelor's degree in engineering or related field
  • Minimum 3 years relevant experience
  • Knowledge of ISO, QSR, UL, MDD, TGA standards

Work Rights

Not specified

Tailored Resume

Cover Letter