Quality Engineer Iii

The Integer Group

Not specified in the job description.
Fda quality system regulations compliance
Iso 13485 standards knowledge
Statistical analysis and spc expertise
The Integer Group is seeking a Quality Engineer III to ensure compliance with quality management systems and regulatory standards in the medical device manufacturing sector. The ideal candidate will have a Bachelor's degree in engineering, at least three years of relevant experience, and a strong technical background in quality assurance practices

Job Summary

  • The role requires maintaining company compliance with FDA Quality System Regulations and ISO 13485 standards while actively participating in internal audits.
  • Candidates will lead the implementation of continuous improvement projects and serve as a subject matter expert for statistical methods like SPC, FMEA, and DOE.
  • The position involves providing direction to product development teams to successfully launch new products into active production in a timely and cost-effective manner.

Matching Summary

Match Score: 85

The Integer Group is seeking a Quality Engineer III to ensure compliance with quality management systems and regulatory standards in the medical device manufacturing sector. The ideal candidate will have a Bachelor's degree in engineering, at least three years of relevant experience, and a strong technical background in quality assurance practices.

Skills & Requirements

Must-have

  • FDA Quality System Regulations compliance
  • ISO 13485 standards knowledge
  • Statistical analysis and SPC expertise
  • FMEA and DOE process validation
  • Supplier approval and audit support

Nice-to-have

  • Excellent verbal and written communication
  • Project management support experience
  • Continuous improvement leadership
  • ERP system familiarity
  • Safety committee participation

Key Requirements

  • Bachelor's degree in engineering or equivalent
  • Minimum 3 years manufacturing experience
  • Experience in medical devices preferred

Work Rights

Not specified

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