Quality Engineer Iii

486

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 FDA Quality System Regulations and ISO 13485 standards while actively participating in quality management and continuous improvement initiatives within the medical device manufacturing sector. The ideal candidate will have a bachelor's degree in engineering, a minimum of three years of relevant experience, and strong technical knowledge in quality control and regulatory standards

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 statistical methods like SPC, FMEA, and DOE.
  • The position involves directing engineering groups on calibration requirements and supporting supplier qualification processes including corrective actions.

Matching Summary

Match Score: 85

Integer is seeking a Quality Engineer III to ensure compliance with FDA Quality System Regulations and ISO 13485 standards while actively participating in quality management and continuous improvement initiatives within the medical device manufacturing sector. The ideal candidate will have a bachelor's degree in engineering, a minimum of three years of relevant experience, and strong technical knowledge in quality control and regulatory standards.

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 experience

Nice-to-have

  • Excellent verbal and written communication
  • Project management support skills
  • ERP system familiarity
  • Geometric tolerance knowledge
  • Continuous improvement leadership

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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