Quality Engineer Ii

Integer

Base salary not specified; cash-based incentive pr...
Bachelor's degree in engineering or related field
3 years relevant experience in quality engineering
Knowledge of fda regulations and iso standards
The role involves performing advanced quality engineering tasks within the medical device industry while adhering to strict FDA and ISO regulations

Job Summary

  • The role involves performing advanced quality engineering tasks within the medical device industry while adhering to strict FDA and ISO regulations.
  • Candidates will lead test method validations, manage non-conforming material processes, and drive continuous improvement projects to support manufacturing excellence.
  • The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, and a 401(k) plan with matching contributions.

Matching Summary

The role involves performing advanced quality engineering tasks within the medical device industry while adhering to strict FDA and ISO regulations.

Salary

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

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 CAPA and complaint investigations

Nice-to-have

  • Strong written and oral communication skills
  • Positive can-do attitude in high-energy environment
  • Experience with 5S and visual controls
  • Collaborative team player with cross-functional focus
  • Calm demeanor under pressure

Key Requirements

  • Bachelor's degree in engineering or related field
  • Minimum 3 years of relevant experience
  • Awareness of domestic and international regulations (ISO, QSR, UL)
  • Proficiency in Microsoft Office

Work Rights

Not specified

Tailored Resume

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