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 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 SPC, FMEA, DOE, and process validation.
  • The position involves directing engineering groups on calibration requirements and supporting supplier approval processes including corrective and preventive actions.

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
  • SPC FMEA DOE process validation
  • Supplier approval and qualification
  • Internal audit participation

Nice-to-have

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

Key Requirements

  • Bachelor's degree in engineering or equivalent
  • Minimum 3 years manufacturing experience
  • Experience in medical devices preferred
  • Strong statistical analysis skills required

Work Rights

Not specified

Tailored Resume

Cover Letter