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Senior Quality Engineer - Medical Device Manufacturing Lead
Job in
Bloomington, Monroe County, Indiana, 47401, USA
Listed on 2026-08-02
Listing for:
americas-cookmedical
Full Time
position Listed on 2026-08-02
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Americas-Cook Medical in Bloomington, IN, seeks a Quality Engineer to act as the lead quality representative for select product lines in manufacturing. You will ensure compliance with FDA 21 CFR 820, ISO 13485, and other medical device regulations while coordinating with internal and external teams.
Responsibilities include supporting development transfers, implementing production controls, investigating non-conformances, performing root cause analysis, and driving CAPAs.
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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