Quality Engineer Ii- Alden

486

Base: $70,500 - $103,400; bonus/equity: cash-based...
Not specified
Bachelor's degree in engineering
3 years relevant experience
Iso qsr fda regulations knowledge
Integer is seeking a Quality Engineer II to support the manufacturing of medical devices and specialized batteries, focusing on quality management and compliance with regulatory standards. The ideal candidate will have a degree in engineering and relevant experience, demonstrating strong technical aptitude and the ability to work collaboratively

Job Summary

  • The primary purpose of this position is to perform work involving general engineering methods while utilizing advanced quality tools in the medical device industry.
  • You will lead the generation and completion of protocols for test method validations and interface with Manufacturing Engineers to review processes.
  • The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with matching.

Matching Summary

Match Score: 85

Integer is seeking a Quality Engineer II to support the manufacturing of medical devices and specialized batteries, focusing on quality management and compliance with regulatory standards. The ideal candidate will have a degree in engineering and relevant experience, demonstrating strong technical aptitude and the ability to work collaboratively.

Salary

Base: $70,500 - $103,400; Bonus/Equity: Cash-based incentive program; Benefits: Medical, dental, vision, 401(k) match, paid time off

Skills & Requirements

Must-have

  • Bachelor's degree in engineering
  • 3 years relevant experience
  • ISO QSR FDA regulations knowledge
  • Device History Records maintenance
  • Root cause analysis and CAPA
  • Test method validation protocols

Nice-to-have

  • Continuous improvement suggestions
  • 5 Sigma journey participation
  • Cross-functional collaboration skills
  • Positive can-do attitude
  • Microsoft Office proficiency

Key Requirements

  • Bachelor's degree in engineering or related field
  • Minimum 3 years relevant experience
  • Knowledge of ISO, QSR, UL, MDD, TGA standards

Work Rights

Not specified

Tailored Resume

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