Quality Engineer Iii

Integer

**
Fda quality system regulations compliance
Iso 13485 standards knowledge
Statistical packages and spc expertise
** Integer is seeking a Quality Engineer III with a strong background in manufacturing, particularly within the medical device sector. The ideal candidate will possess technical expertise in quality systems and compliance, with a focus on FDA and ISO standards, while embodying the company's core values of innovation, collaboration, and integrity. **

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 continuous improvement projects and act as a subject matter expert for SPC, FMEA, DOE, and process validation.
  • The position involves providing direction to the Product Development team to successfully launch new products into active production in a timely manner.

Matching Summary

Match Score: 75

** Integer is seeking a Quality Engineer III with a strong background in manufacturing, particularly within the medical device sector. The ideal candidate will possess technical expertise in quality systems and compliance, with a focus on FDA and ISO standards, while embodying the company's core values of innovation, collaboration, and integrity. **

Skills & Requirements

Must-have

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

Nice-to-have

  • Excellent verbal and written communication
  • ERP system familiarity
  • Geometric tolerance knowledge
  • Project management support capability
  • Subject matter expert in quality control

Key Requirements

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

Work Rights

Not specified

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