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 regulatory standards in the medical device manufacturing sector. The ideal candidate will have a strong background in engineering, particularly within medical devices, and experience in quality assurance processes

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 act as a subject matter expert for SPC, FMEA, DOE, and process validation.
  • The position involves providing direction to Product Development teams to successfully launch new products into active production in a timely and cost-effective manner.

Matching Summary

Match Score: 85

Integer is seeking a Quality Engineer III to ensure compliance with quality management systems and regulatory standards in the medical device manufacturing sector. The ideal candidate will have a strong background in engineering, particularly within medical devices, and experience in quality assurance processes.

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
  • Continuous improvement leadership
  • ERP system familiarity
  • 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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