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 role involves ensuring customer expectations are met while adhering to FDA regulations and Quality Management Systems in a global medical device organization

Job Summary

  • The role involves ensuring customer expectations are met while adhering to FDA regulations and Quality Management Systems in a global medical device organization.
  • Responsibilities include supporting regulatory inspections, monitoring manufacturing compliance with DMRs, and leading complaint investigations with root cause analysis.
  • The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, life insurance, and a 401(k) plan with matching contributions.

Matching Summary

The role involves ensuring customer expectations are met while adhering to FDA regulations and Quality Management Systems in a global medical device organization.

Salary

Base: $64,350 - $85,800; Bonus/Equity: Cash-based incentive program; Benefits: Medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 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 CAPA
  • Test method validation protocols

Nice-to-have

  • Continuous improvement projects
  • Collaborative team environment
  • Process capability studies
  • 5S workplace organization
  • Data analysis practices

Key Requirements

  • Entry level engineering experience
  • Knowledge of FDA regulations
  • Understanding of QMS requirements

Work Rights

Not specified

Tailored Resume

Cover Letter