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Senior Medical Device Quality Engineer - ISO 13485 & FDA
Job in
Lake Forest, Lake County, Illinois, 60045, USA
Listed on 2026-07-26
Listing for:
ICU Medical
Full Time
position Listed on 2026-07-26
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
ICU Medical is seeking a Sr. Quality Engineer to provide quality support for ICU Medical Hardware and development, ensuring compliance with ISO 13485, ISO 14971, 21 CFR Part 820, and other standards.
The role reports to the Quality Manager and ensures quality is built into products during development and manufacturing. Responsibilities include coordinating product changes, performing risk analyses, supporting FDA responses, and ensuring readiness for audits while driving continual quality
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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