Quality Engineer Iii

Integer

Fda qsr and iso 13485 compliance
Statistical analysis spc fmea doe
Design control and process validation
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 safety protocols are followed when working near hazardous chemicals.

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 QSR and ISO 13485 compliance
  • Statistical analysis SPC FMEA DOE
  • Design control and process validation
  • Supplier approval and audit support
  • NCR initiation and closure management

Nice-to-have

  • Excellent verbal and written communication
  • Project management support experience
  • ERP system knowledge
  • Geometric tolerance expertise
  • Safety committee participation

Key Requirements

  • Bachelor's degree in engineering or equivalent
  • Minimum 3 years manufacturing experience
  • Experience in medical device industry preferred

Work Rights

Not specified

Tailored Resume

Cover Letter