Quality Engineer Ii-2

The Integer Group

Not specified (assumed standard office hours unless further clarified).
Bachelor's degree in engineering
3 years relevant experience
Knowledge of fda regulations and iso standards
The Integer Group is seeking a Quality Engineer II-2 to support quality assurance in the medical device manufacturing sector. The role emphasizes collaboration, innovation, and adherence to regulatory standards while focusing on continuous improvement and customer satisfaction

Job Summary

  • The primary purpose of this position is to perform advanced quality engineering work within the medical device industry while adhering to strict FDA and ISO regulations.
  • You will lead the generation of test method validations, review Bill of Materials changes, and manage non-conforming material processes including complaint investigations.
  • This role requires embedding a culture of quality ownership by supporting internal audits, ensuring compliance with Quality Management Systems, and driving continuous improvement initiatives.

Matching Summary

Match Score: 85

The Integer Group is seeking a Quality Engineer II-2 to support quality assurance in the medical device manufacturing sector. The role emphasizes collaboration, innovation, and adherence to regulatory standards while focusing on continuous improvement and customer satisfaction.

Skills & Requirements

Must-have

  • Bachelor's degree in engineering
  • 3 years relevant experience
  • Knowledge of FDA regulations and ISO standards
  • Experience with QMS and Device History Records
  • Root cause analysis and CAPA implementation

Nice-to-have

  • Continuous improvement methodologies
  • Strong written and oral communication skills
  • Ability to work independently and collaboratively
  • Positive can-do attitude in high-energy environments

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)
  • Proficiency in Microsoft Office

Work Rights

Not specified

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