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 the implementation of continuous improvement projects and serve 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 and cost-effective 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 SPC expertise
  • FMEA and DOE process validation
  • Supplier approval and qualification

Nice-to-have

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

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