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 support its mission of providing innovative technologies and services in the medical device industry, ensuring adherence to quality management systems and regulatory requirements. The ideal candidate will have a relevant engineering degree and experience, with a focus on collaboration, innovation, and quality assurance

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, company policies, and Quality Management Systems.
  • The role includes leading test method validations, managing non-conforming materials, and supporting continuous improvement projects to achieve quality KPIs.

Matching Summary

Match Score: 85

Integer is seeking a Quality Engineer II to support its mission of providing innovative technologies and services in the medical device industry, ensuring adherence to quality management systems and regulatory requirements. The ideal candidate will have a relevant engineering degree and experience, with a focus on collaboration, innovation, and quality assurance.

Salary

Base: $70,500 - $103,400; Bonus/Equity: Cash-based incentive program included; Benefits: Medical, dental, vision, 401(k) matching, 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
  • Collaborative team player with cross-functional experience
  • Familiarity with Microsoft Office suite
  • Experience with process capability studies

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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