Quality Engineer Iii

Integer

Not specified
Fda quality system regulations compliance
Iso 13485 standards knowledge
Statistical analysis and spc expertise
Integer is seeking a Quality Engineer III to ensure compliance with quality management systems and regulations within a medical device manufacturing environment. The ideal candidate will possess strong technical knowledge, experience with FDA QSR and ISO 13485, and skills in data analysis and quality improvement methodologies

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 providing direction for product development launches.

Matching Summary

Match Score: 85

Integer is seeking a Quality Engineer III to ensure compliance with quality management systems and regulations within a medical device manufacturing environment. The ideal candidate will possess strong technical knowledge, experience with FDA QSR and ISO 13485, and skills in data analysis and quality improvement methodologies.

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
  • Continuous improvement leadership
  • ERP system proficiency
  • Geometric tolerance knowledge

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

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