Quality Engineer Ii- Alden

Integer

Base: $70,500 - $103,400; bonus/equity: cash-based...
Not specified
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 enhance their medical device manufacturing processes, ensuring high standards of quality and compliance with industry regulations. The ideal candidate will have a bachelor’s degree in engineering or a related field, along with relevant experience, and will embody Integer’s core values of customer focus, innovation, collaboration, inclusion, candor, and integrity

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 support regulatory inspections, monitor manufacturing compliance, and ensure complete and correct Device History Records are maintained.
  • The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with matching contributions.

Matching Summary

Match Score: 85

Integer is seeking a Quality Engineer II to enhance their medical device manufacturing processes, ensuring high standards of quality and compliance with industry regulations. The ideal candidate will have a bachelor’s degree in engineering or a related field, along with relevant experience, and will embody Integer’s core values of customer focus, innovation, collaboration, inclusion, candor, and integrity.

Salary

Base: $70,500 - $103,400; Bonus/Equity: Cash-based incentive program; Benefits: Medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) match

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 CAPA and root cause analysis
  • Ability to lead test method validations

Nice-to-have

  • Positive can-do attitude in high-energy environment
  • Strong written and oral communication skills
  • Experience with continuous improvement methodologies
  • Familiarity with 5S and visual controls
  • Collaborative team player with cross-functional experience

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)
  • Good knowledge of Microsoft Office

Work Rights

Not specified

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