Quality Engineer I

The Integer Group

Base: $64,350 - $85,800; bonus/equity: cash-based ...
Not specified (potentially hybrid or onsite).
Fda regulations compliance
Device history records maintenance
Bill of materials review
The Integer Group is seeking a Quality Engineer I, an entry-level position focused on ensuring compliance with quality standards in manufacturing and product design. The role emphasizes collaboration, adherence to regulatory requirements, and continuous improvement in a culture that values innovation and integrity

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 DMR, and review the adequacy of changes to Bill of Materials, Assembly Procedures, and FMEAs.
  • The company offers a comprehensive benefits package including medical, dental, vision, disability, life insurance, and immediate eligibility for a 401(k) plan with company matching.

Matching Summary

Match Score: 85

The Integer Group is seeking a Quality Engineer I, an entry-level position focused on ensuring compliance with quality standards in manufacturing and product design. The role emphasizes collaboration, adherence to regulatory requirements, and continuous improvement in a culture that values innovation and integrity.

Salary

Base: $64,350 - $85,800; Bonus/Equity: Cash-based incentive program; Benefits: Medical, dental, vision, 401(k) match, 10 days holidays

Skills & Requirements

Must-have

  • FDA regulations compliance
  • Device History Records maintenance
  • Bill of Materials review
  • FMEA and Control Plans
  • Test method validation protocols
  • Root cause analysis
  • CAPA activities

Nice-to-have

  • Continuous improvement projects
  • Product transfer support
  • 5S workplace organization
  • Standardized problem solving methodologies
  • Collaborative team environment

Key Requirements

  • Entry level engineer experience
  • Knowledge of QMS and FDA regulations
  • Ability to perform root cause analysis

Work Rights

Not specified

Tailored Resume

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