Quality Engineer Iii

The Integer Group

Not specified (assumed hybrid based on industry standards).
Fda quality system regulations compliance
Iso 13485 standards knowledge
Statistical process control (spc) expertise
The Integer Group is seeking a Quality Engineer III with experience in the manufacturing environment, preferably within medical devices. The role emphasizes adherence to quality management systems, continuous improvement, and compliance with FDA regulations and ISO 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 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

The Integer Group is seeking a Quality Engineer III with experience in the manufacturing environment, preferably within medical devices. The role emphasizes adherence to quality management systems, continuous improvement, and compliance with FDA regulations and ISO standards.

Skills & Requirements

Must-have

  • FDA Quality System Regulations compliance
  • ISO 13485 standards knowledge
  • Statistical Process Control (SPC) expertise
  • FMEA and DOE methodology application
  • Process validation leadership
  • Supplier approval and qualification

Nice-to-have

  • Excellent verbal and written communication skills
  • Project management support experience
  • ERP system familiarity
  • Geometric tolerance knowledge
  • Continuous improvement project leadership
  • Safety committee participation

Key Requirements

  • Bachelor's degree in engineering or equivalent
  • Minimum 3 years manufacturing experience
  • Experience in medical devices preferred
  • Strong statistical analysis skills
  • Knowledge of FDA QSR and ISO 13485

Work Rights

Not specified

Tailored Resume

Cover Letter