Quality Engineer Iii

Integer

Fda quality system regulations compliance
Iso 13485 standards knowledge
Statistical packages and microsoft office
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 implementation of continuous improvement projects and act as a subject matter expert for SPC, FMEA, DOE, and process validation.
  • The position involves providing direction to Product Development teams to successfully launch new products into active production in a timely 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 packages and Microsoft Office
  • SPC FMEA DOE process validation
  • Supplier approval and qualification

Nice-to-have

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

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter