Quality Engineer

Karwell Technologies • Chicago, Illinois, United States • Posted May 16, 2026

Location Chicago, Illinois
Job Type Full-time
Category other-general
Posted May 16, 2026
Job Description:



  • Quality Engineer / Quality Compliance Engineer with experience supporting remediation efforts and maintaining quality standards within regulated medical device, pharmaceutical, OTC drug, and cosmetic environments.

  • Responsible for supporting Quality Management Systems (QMS), Design Controls, CAPA, Risk Management, supplier quality activities, process validation, and regulatory compliance while ensuring adherence to FDA and ISO quality standards.


Roles & Responsibilities:


  • Provide quality engineering support for Product Development, QMS, Design Controls, Design History Files (DHF), CAPA, Risk Management, and CE Technical File activities.

  • Support remediation projects and ensure compliance with FDA 21 CFR Part 820, ISO 13485, and applicable domestic/international regulations.

  • Collaborate with sup...

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