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Lead SaMD Quality Engineer - Digital Health & Regulatory
Job in
North Chicago, Lake County, Illinois, 60086, USA
Listed on 2026-09-03
Listing for:
Allergan
Full Time
position Listed on 2026-09-03
Job specializations:
-
Business
Regulatory Compliance Specialist
Job Description & How to Apply Below
Abb Vie seeks a Lead Digital Health Quality Engineer to drive design controls, DHF management, software validation, and risk management across the software lifecycle. You will author and review QMS documents, support regulatory submissions, and lead continuous improvement in SaMD quality.
Strong cross-functional collaboration and cybersecurity awareness are required. Role requires coordinating audits, CAPA activities, and ensuring compliance with IEC 62304, ISO 14971, and applicable regulations.
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