Quality Engineer Ii- Alden

Integer

Base: $70,500 - $103,400; bonus/equity: cash-based...
Not specified (assumed to be hybrid based on industry standards).
Bachelor's degree in engineering
3 years relevant experience
Fda regulations and qms knowledge
Integer is seeking a Quality Engineer II who will apply engineering concepts and advanced quality tools to ensure compliance and improvement in medical device manufacturing. The ideal candidate will have a Bachelor's degree in engineering or a related field, along with relevant experience, and will contribute to a culture of collaboration, innovation, 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 with DMR, and ensure complete 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 who will apply engineering concepts and advanced quality tools to ensure compliance and improvement in medical device manufacturing. The ideal candidate will have a Bachelor's degree in engineering or a related field, along with relevant experience, and will contribute to a culture of collaboration, innovation, and integrity.

Salary

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

Skills & Requirements

Must-have

  • Bachelor's degree in engineering
  • 3 years relevant experience
  • FDA regulations and QMS knowledge
  • ISO and QSR standards awareness
  • Root cause analysis and CAPA
  • Test method validation protocols
  • Bill of Materials review

Nice-to-have

  • Continuous improvement mindset
  • Collaborative team player
  • Positive can-do attitude
  • Strong written communication skills
  • Data analysis proficiency
  • 5S workplace organization knowledge
  • Process capability studies experience

Key Requirements

  • Bachelor's degree in engineering or related field
  • Minimum 3 years of relevant experience
  • Knowledge of FDA, ISO, QSR, UL, MDD, TGA regulations
  • Microsoft Office proficiency

Work Rights

Not specified

Tailored Resume

Cover Letter