Quality Engineer Iii

576

Not specified
Fda quality system regulations compliance
Iso 13485 standards knowledge
Spc fmea doe process validation
Integer is seeking a Quality Engineer III with a strong background in manufacturing, particularly in the medical device sector. The role involves ensuring compliance with quality standards, conducting audits, and supporting product development with a focus on continuous improvement

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 act as a subject matter expert for SPC, FMEA, DOE, and process validation.
  • 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

Integer is seeking a Quality Engineer III with a strong background in manufacturing, particularly in the medical device sector. The role involves ensuring compliance with quality standards, conducting audits, and supporting product development with a focus on continuous improvement.

Skills & Requirements

Must-have

  • FDA Quality System Regulations compliance
  • ISO 13485 standards knowledge
  • SPC FMEA DOE process validation
  • Bachelor's degree in engineering
  • 3 years manufacturing experience

Nice-to-have

  • Excellent verbal and written communication
  • Strong data analysis skills
  • ERP system familiarity
  • Geometric tolerance expertise
  • Continuous improvement leadership

Key Requirements

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

Work Rights

Not specified

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