Quality Engineer I

Integer

Base: $64,350 - $85,800; bonus/equity: cash-based ...
Fda regulations compliance
Quality management systems qms
Device history records maintenance
The primary purpose of this position is to ensure that Integer's internal and external customer expectations are met or exceeded while adhering to FDA regulations and Quality Management Systems

Job Summary

  • The primary purpose of this position is to ensure that Integer's internal and external customer expectations are met or exceeded while adhering to FDA regulations and Quality Management Systems.
  • You will support regulatory inspections, monitor manufacturing compliance with Device Master Records, and lead complaint investigations including root cause analysis for corrective actions.
  • The company offers a comprehensive benefits package including medical, dental, vision, 401(k) matching, and 80 hours of designated holidays per year.

Matching Summary

The primary purpose of this position is to ensure that Integer's internal and external customer expectations are met or exceeded while adhering to FDA regulations and Quality Management Systems.

Salary

Base: $64,350 - $85,800; Bonus/Equity: Cash-based incentive program available; Benefits: Medical, dental, vision, disability, life insurance, 401(k) match

Skills & Requirements

Must-have

  • FDA regulations compliance
  • Quality Management Systems QMS
  • Device History Records maintenance
  • Non-conforming material disposition
  • Root cause analysis and CAPA
  • Bill of Materials review

Nice-to-have

  • Continuous improvement projects
  • Collaborative team environment
  • Process validation experience
  • Data analysis practices
  • 5S workplace organization

Key Requirements

  • Entry level engineering background
  • Knowledge of FDA regulations
  • Experience with QMS and DMR
  • Ability to perform root cause analysis

Work Rights

Not specified

Tailored Resume

Cover Letter