Quality Engineer Iii

Integer

Not specified
Fda quality system regulations compliance
Iso 13485 standards knowledge
Spc fmea doe process validation expertise
Integer is seeking a Quality Engineer III to ensure adherence to quality management systems and regulatory requirements, particularly in the medical device sector. The ideal candidate should possess strong technical skills, experience in manufacturing, and a thorough understanding of FDA Quality System Regulations and ISO 13485 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 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 is seeking a Quality Engineer III to ensure adherence to quality management systems and regulatory requirements, particularly in the medical device sector. The ideal candidate should possess strong technical skills, experience in manufacturing, and a thorough understanding of FDA Quality System Regulations and ISO 13485 standards.

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 statistical analysis capabilities
  • ERP system familiarity
  • Project management support experience
  • Safety committee participation willingness

Key Requirements

  • Minimum Bachelor's degree in engineering
  • 3 years working experience in manufacturing environment
  • Experience preferably in medical devices
  • Knowledge of FDA QSR and ISO 13485

Work Rights

Not specified

Tailored Resume

Cover Letter