Quality Engineer Iii

Integer

Fda quality system regulations compliance
Iso 13485 standards knowledge
Statistical analysis 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 continuous improvement projects and act as a subject matter expert for statistical methods like SPC, FMEA, and DOE.
  • The position involves supporting supplier qualification, managing corrective actions, and ensuring the successful launch of new products into active production.

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 and SPC expertise
  • FMEA and DOE process validation
  • Supplier approval and audit support

Nice-to-have

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

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