Quality Engineer Iii

Integer

Bachelor's degree in engineering
3 years manufacturing experience
Fda qsr and iso 13485 knowledge
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 supporting supplier approval, managing corrective actions, and providing direction to the engineering group for new product launches.

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

  • Bachelor's degree in engineering
  • 3 years manufacturing experience
  • FDA QSR and ISO 13485 knowledge
  • SPC FMEA DOE process validation
  • Supplier approval and qualification

Nice-to-have

  • Excellent verbal and written communication
  • Project management support skills
  • Continuous improvement project leadership
  • ERP system technical knowledge
  • Safety committee participation

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter