Quality Engineer Iii

Integer

Not specified
Fda quality system regulations compliance
Iso 13485 standards knowledge
Spc fmea doe process validation expertise
Integer seeks a Quality Engineer III to uphold compliance with FDA Quality System Regulations and ISO 13485 standards while leading quality assurance initiatives in a collaborative and innovative environment. The role requires a Bachelor's degree in engineering and a minimum of three years of experience in a manufacturing setting, ideally within the medical device industry

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 SPC, FMEA, DOE, and process validation.
  • The position involves providing direction to the Product Development team to successfully launch new products into active production in a timely manner.

Matching Summary

Match Score: 85

Integer seeks a Quality Engineer III to uphold compliance with FDA Quality System Regulations and ISO 13485 standards while leading quality assurance initiatives in a collaborative and innovative environment. The role requires a Bachelor's degree in engineering and a minimum of three years of experience in a manufacturing setting, ideally within the medical device industry.

Skills & Requirements

Must-have

  • FDA Quality System Regulations compliance
  • ISO 13485 standards knowledge
  • SPC FMEA DOE process validation expertise
  • Bachelor's degree in engineering
  • 3 years manufacturing experience
  • Supplier approval and qualification support

Nice-to-have

  • Excellent verbal and written communication skills
  • Strong data analysis in statistical packages
  • ERP system familiarity
  • Project management support capability
  • Safety committee participation willingness

Key Requirements

  • Minimum Bachelor's degree in engineering
  • 3 years working experience in manufacturing environment
  • Experience preferably in medical devices industry

Work Rights

Not specified

Tailored Resume

Cover Letter