Quality Engineer I

The Integer Group

Base: $64,350 - $85,800; bonus/equity: cash-based ...
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Fda regulations compliance
Device history records maintenance
Bill of materials review
** The Integer Group seeks a Quality Engineer I, an entry-level position focused on ensuring product and manufacturing quality within the medical device sector. The role emphasizes collaboration, adherence to regulatory standards, and engagement in continuous improvement initiatives to meet customer expectations. **

Job Summary

  • This entry-level role supports regulatory inspections, audits, and investigations while ensuring compliance with FDA regulations and Quality Management Systems.
  • The engineer is responsible for developing test methods, reviewing design changes, and managing non-conforming materials through CAPA activities.
  • The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, and a 401(k) plan with matching contributions.

Matching Summary

Match Score: 75

** The Integer Group seeks a Quality Engineer I, an entry-level position focused on ensuring product and manufacturing quality within the medical device sector. The role emphasizes collaboration, adherence to regulatory standards, and engagement in continuous improvement initiatives to meet customer expectations. **

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
  • Device History Records maintenance
  • Bill of Materials review
  • FMEA and Control Plans
  • Test method validations
  • CAPA and root cause analysis
  • Incoming In-Process Final Inspection procedures

Nice-to-have

  • Continuous improvement projects
  • Product transfer assistance
  • 5S workplace organization
  • Collaborative team engagement
  • Data analysis practices
  • Standardized problem solving methodologies

Key Requirements

  • Entry level engineer experience
  • Knowledge of QMS and FDA regulations
  • Ability to follow safety and security requirements

Work Rights

Not specified

Tailored Resume

Cover Letter