Quality Engineer Iii

Integer

Not specified
Fda qsr and iso 13485 compliance
Statistical analysis with spc and fmea
Process validation and doe expertise
Integer is seeking a Quality Engineer III to ensure compliance with quality regulations and support product development in the medical device sector. The ideal candidate will have a background in engineering, strong analytical skills, and experience in manufacturing, particularly with FDA and ISO standards

Job Summary

  • The role requires maintaining company compliance with FDA Quality System Regulations and ISO 13485 standards while adhering to core values like integrity and candor.
  • Candidates will lead continuous improvement projects using statistical methods such as SPC, FMEA, and Design of Experiments (DOE) to ensure product reliability.
  • The position involves directing supplier approvals, managing corrective actions, and supporting FDA and ISO inspections for medical device products.

Matching Summary

Match Score: 85

Integer is seeking a Quality Engineer III to ensure compliance with quality regulations and support product development in the medical device sector. The ideal candidate will have a background in engineering, strong analytical skills, and experience in manufacturing, particularly with FDA and ISO standards.

Skills & Requirements

Must-have

  • FDA QSR and ISO 13485 compliance
  • Statistical analysis with SPC and FMEA
  • Process validation and DOE expertise
  • Bachelor's degree in engineering
  • 3 years manufacturing experience

Nice-to-have

  • Excellent verbal and written communication
  • ERP system knowledge
  • Geometric tolerance understanding
  • Project management support skills
  • 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

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