Quality Engineer Ii- Alden

Integer

Base: $70,500 - $103,400; bonus/equity: cash-based...
Hybrid
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 support quality management in the medical device industry, emphasizing collaboration, innovation, and adherence to regulatory standards. The role involves applying engineering concepts to improve product quality and process efficiency while ensuring compliance with safety regulations

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 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 support quality management in the medical device industry, emphasizing collaboration, innovation, and adherence to regulatory standards. The role involves applying engineering concepts to improve product quality and process efficiency while ensuring compliance with safety regulations.

Salary

Base: $70,500 - $103,400; Bonus/Equity: Cash-based incentive program; Benefits: Medical, dental, vision, 401(k) match, 80 hours holidays

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 CAPA investigations and root cause analysis

Nice-to-have

  • Positive can-do attitude in high energy environment
  • Strong written and oral communication skills
  • Collaborative team player with cross-functional experience
  • Familiarity with continuous improvement methodologies
  • Calm demeanor under production pressure

Key Requirements

  • Bachelor's degree in engineering
  • 3 years relevant experience
  • 7+ years experience if no degree
  • Knowledge of Domestic and International Regulations

Work Rights

Not specified

Tailored Resume

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