Senior Quality Engineer

Integer

Base: $114,675 - $168,190; bonus/equity: cash-base...
Bachelor's degree in engineering
7+ years progressive engineering experience
Six sigma green belt certification minimum
The role involves applying intensive engineering knowledge to ensure medical device products meet or exceed customer expectations while adhering to strict FDA and ISO regulations

Job Summary

  • The role involves applying intensive engineering knowledge to ensure medical device products meet or exceed customer expectations while adhering to strict FDA and ISO regulations.
  • Candidates will lead continuous improvement projects, manage complaint investigations, and drive plant CAPA activities using statistical quality control methods like DOE and Hypotheses Testing.
  • The position offers a competitive salary range of $114,675 - $168,190 along with comprehensive benefits including immediate eligibility for medical, dental, vision, and a 401(k) plan with company matching.

Matching Summary

The role involves applying intensive engineering knowledge to ensure medical device products meet or exceed customer expectations while adhering to strict FDA and ISO regulations.

Salary

Base: $114,675 - $168,190; Bonus/Equity: Cash-based incentive program available; Benefits: Medical, dental, vision, disability, life insurance, 401(k) match, 10 days holidays

Skills & Requirements

Must-have

  • Bachelor's degree in engineering
  • 7+ years progressive engineering experience
  • Six Sigma Green Belt certification minimum
  • ISO QSR FDA regulatory knowledge
  • Process capability studies and Cpk analysis
  • Device History Records maintenance
  • Non-conforming material disposition

Nice-to-have

  • Master's degree in engineering field
  • Six Sigma Black Belt preferred
  • Experience leading product transfers
  • Mentoring junior engineers
  • 5S workplace organization expertise
  • International regulation awareness
  • High energy production environment adaptability

Key Requirements

  • Minimum Bachelor's degree in engineering
  • 7+ years of relevant engineering experience
  • Six Sigma Green Belt certification required
  • Knowledge of ISO, QSR, UL, MDD standards
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

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