Quality Engineer Iii

Integer

Not specified
Fda quality system regulations compliance
Iso 13485 standards knowledge
Statistical packages and spc expertise
Integer is seeking a Quality Engineer III to ensure compliance with FDA and ISO standards while maintaining quality management systems. The ideal candidate will have a background in engineering, particularly in the medical device manufacturing sector, with a strong focus on quality assurance and 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 serve 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 to ensure compliance with FDA and ISO standards while maintaining quality management systems. The ideal candidate will have a background in engineering, particularly in the medical device manufacturing sector, with a strong focus on quality assurance and continuous improvement.

Skills & Requirements

Must-have

  • FDA Quality System Regulations compliance
  • ISO 13485 standards knowledge
  • Statistical packages and SPC expertise
  • FMEA DOE process validation skills
  • Supplier approval and qualification experience

Nice-to-have

  • Excellent verbal and written communication
  • Project management support capabilities
  • Continuous improvement project leadership
  • ERP system technical knowledge
  • Geometric tolerance understanding

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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