Quality Engineer Ii

128

Base salary + cash-based incentive program; compre...
Bachelor's degree in engineering or related field
3 years relevant experience in quality engineering
Knowledge of fda regulations and iso standards
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.
  • Our total rewards program includes base salary, a cash-based incentive program, comprehensive medical/dental/vision benefits, and immediate 401(k) matching.

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 and cash-based incentive program; Comprehensive benefits package including medical, dental, vision, disability, life insurance; 401(k) plan with company matching contributions

Skills & Requirements

Must-have

  • Bachelor's degree in engineering or related field
  • 3 years relevant experience in quality engineering
  • Knowledge of FDA regulations and ISO standards
  • Experience with QMS and Device History Records
  • Ability to lead complaint investigations and CAPA activities

Nice-to-have

  • Strong written and oral communication skills
  • Positive can-do attitude in high-energy environments
  • Experience with continuous improvement methodologies
  • Familiarity with Microsoft Office suite
  • Calm demeanor in changing production settings

Key Requirements

  • Bachelor's degree in engineering or related field
  • Minimum 3 years relevant experience
  • Awareness of Domestic and International Regulations (ISO, QSR, UL)
  • US citizenship not explicitly required but US applicants mentioned

Work Rights

Not specified

Tailored Resume

Cover Letter