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 non-conforming materials.
  • The company offers a comprehensive benefits package including medical, dental, vision, 401(k) matching, and paid time off immediately upon eligibility.

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; Benefits: Comprehensive package with immediate eligibility including medical, dental, vision, disability, life insurance, and 401(k) matching

Skills & Requirements

Must-have

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

Nice-to-have

  • Continuous improvement projects
  • Collaborative team environment
  • Process capability studies
  • 5S workplace organization
  • Standardized problem solving methodologies

Key Requirements

  • Entry level engineering background
  • Knowledge of FDA regulations
  • Experience with QMS systems
  • Ability to perform root cause analysis
  • Understanding of Medical Device OEM processes

Work Rights

Not specified

Tailored Resume

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