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

Job Summary

  • The role requires maintaining company compliance with FDA Quality System Regulations and ISO 13485 standards.
  • Candidates will lead 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.

Skills & Requirements

Must-have

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

Nice-to-have

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

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter