Quality Engineer Iii

Integer

Fda quality system regulations compliance
Iso 13485 standards knowledge
Statistical analysis 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 the implementation of continuous improvement projects and act as a subject matter expert for SPC, FMEA, and process validation.
  • The position involves supporting supplier approval, managing corrective actions, and assisting with FDA and ISO inspections.

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 analysis and SPC expertise
  • FMEA and DOE process validation
  • Supplier approval and audit experience

Nice-to-have

  • Excellent verbal and written communication
  • Project management support skills
  • Continuous improvement leadership
  • ERP system familiarity
  • Geometric tolerance knowledge

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter