Quality Engineer Iii

Integer

Fda quality system regulations compliance
Iso 13485 standards knowledge
Statistical process control spc expertise
The role requires maintaining company compliance with FDA Quality System Regulations and ISO 13485 standards while actively participating in internal audits

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

The role requires maintaining company compliance with FDA Quality System Regulations and ISO 13485 standards while actively participating in internal audits.

Skills & Requirements

Must-have

  • FDA Quality System Regulations compliance
  • ISO 13485 standards knowledge
  • Statistical process control SPC expertise
  • FMEA and DOE methodology application
  • Process validation leadership
  • Supplier approval and qualification support

Nice-to-have

  • Excellent verbal and written communication skills
  • Project management support experience
  • Continuous improvement project leadership
  • Subject matter expert in quality systems
  • ERP system familiarity

Key Requirements

  • Bachelor's degree in engineering or equivalent
  • Minimum 3 years manufacturing experience
  • Experience in medical devices preferred
  • Strong technical knowledge in required discipline

Work Rights

Not specified

Tailored Resume

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