Quality Engineer Iii

Integer

Fda quality system regulations compliance
Iso 13485 standards knowledge
Spc fmea doe process validation
The role requires maintaining company compliance with FDA Quality System Regulations and ISO 13485 standards

Job Summary

  • The role requires maintaining company compliance with FDA Quality System Regulations and ISO 13485 standards.
  • Candidates will lead implementation of continuous improvement projects and act as a subject matter expert for SPC, FMEA, and DOE.
  • The position involves providing direction for product development to successfully launch new products into active production.

Matching Summary

The role requires maintaining company compliance with FDA Quality System Regulations and ISO 13485 standards.

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
  • Project management support

Key Requirements

  • Bachelor's degree in engineering
  • 3 years manufacturing environment experience
  • Experience in medical devices preferred

Work Rights

Not specified

Tailored Resume

Cover Letter