Quality Engineer Ii- Alden

Integer

Base: $70,500 - $103,400; bonus/equity: cash-based...
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Bachelor's degree in engineering or related field
3 years relevant experience in quality engineering
Knowledge of fda regulations and iso standards
** Integer is seeking a Quality Engineer II to join their team, focusing on quality assurance within the medical device industry. The ideal candidate will hold a degree in engineering and possess relevant experience, demonstrating strong technical aptitude and the ability to work both independently and 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 ensure internal and external customer expectations are met by adhering to FDA regulations, Quality Management Systems, and company policies.
  • The role includes leading test method validations, managing non-conforming materials, and supporting continuous improvement projects to achieve differentiated quality.

Matching Summary

Match Score: 75

** Integer is seeking a Quality Engineer II to join their team, focusing on quality assurance within the medical device industry. The ideal candidate will hold a degree in engineering and possess relevant experience, demonstrating strong technical aptitude and the ability to work both independently and collaboratively. **

Salary

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

Skills & Requirements

Must-have

  • Bachelor's degree in engineering or related field
  • 3 years relevant experience in quality engineering
  • Knowledge of FDA regulations and ISO standards
  • Experience with QMS and Device History Records
  • Ability to lead root cause analysis and CAPA

Nice-to-have

  • Strong written and oral communication skills
  • Positive can-do attitude in high-energy environment
  • Collaborative team player with cross-functional experience
  • Familiarity with Microsoft Office suite
  • Experience with product transfers and process validations

Key Requirements

  • Bachelor's degree in engineering or related field
  • Minimum 3 years of relevant experience
  • Awareness of domestic and international regulations (ISO, QSR, UL)

Work Rights

Not specified

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