Quality Engineer Iii

Integer

Fda quality system regulations compliance
Iso 13485 standards knowledge
Statistical analysis with spc and fmea
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 methods like SPC, FMEA, and DOE.
  • The position involves providing direction to the Product Development team 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 analysis with SPC and FMEA
  • Process validation and DOE expertise
  • Supplier approval and audit experience
  • Design control and development support

Nice-to-have

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

Key Requirements

  • Bachelor's degree in engineering or equivalent
  • Minimum 3 years manufacturing experience
  • Experience in medical devices preferred
  • Strong technical knowledge in required discipline

Work Rights

Not specified

Tailored Resume

Cover Letter