Quality Engineer Ii- Alden

Integer

Base: $70,500 - $103,400; bonus/equity: cash-based...
Not specified (assumed hybrid or onsite based on industry standards).
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 product quality in the medical device sector through advanced engineering methods and collaboration. The role emphasizes adherence to quality management systems, regulatory compliance, and continuous improvement in a culture that values customer focus, innovation, and teamwork

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, supporting regulatory inspections, and managing non-conforming material processes to prevent re-occurrence.

Matching Summary

Match Score: 85

Integer is seeking a Quality Engineer II to enhance product quality in the medical device sector through advanced engineering methods and collaboration. The role emphasizes adherence to quality management systems, regulatory compliance, and continuous improvement in a culture that values customer focus, innovation, and teamwork.

Salary

Base: $70,500 - $103,400; Bonus/Equity: Cash-based incentive program included; Benefits: Medical, dental, vision, 401(k) match, 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 CAPA investigations and root cause analysis

Nice-to-have

  • Strong written and oral communication skills
  • Positive can-do attitude in high-energy environment
  • Experience with continuous improvement methodologies
  • Familiarity with Microsoft Office suite
  • Collaborative team player mindset

Key Requirements

  • Bachelor's degree in engineering or related field
  • 3 years relevant experience (or 7+ years without degree)
  • Awareness of domestic and international regulations (ISO, QSR, UL)

Work Rights

Not specified

Tailored Resume

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