Quality Engineer Iii

Integer

Not specified (please clarify with the job posting)
Fda quality system regulations compliance
Iso 13485 standards knowledge
Statistical analysis and spc expertise
Integer is seeking a Quality Engineer III to maintain compliance with FDA and ISO standards, lead quality assurance initiatives, and support product development in a manufacturing environment, particularly in the medical device sector

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: 75

Integer is seeking a Quality Engineer III to maintain compliance with FDA and ISO standards, lead quality assurance initiatives, and support product development in a manufacturing environment, particularly in the medical device sector.

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 understanding
  • Safety committee participation

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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