Quality Engineer Iii

Integer

Fda quality system regulations compliance
Iso 13485 standards knowledge
Statistical packages and 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 continuous improvement projects and act as a subject matter expert for statistical process control, FMEA, and process validation.
  • The position involves providing direction to the engineering group for product development launches and supporting supplier approval and qualification processes.

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 packages and SPC expertise
  • FMEA and DOE process validation
  • Bachelor's degree in engineering

Nice-to-have

  • Excellent verbal and written communication
  • ERP system familiarity
  • Geometric tolerance knowledge
  • Project management support experience
  • Safety committee participation

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter