More jobs:
CAPA & Complaint Quality Engineer
Job in
Racine, Racine County, Wisconsin, 53404, USA
Listed on 2026-07-26
Listing for:
Werfenlife SA.
Full Time
position Listed on 2026-07-26
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Werfen is seeking a Quality Assurance Systems Engineer to oversee CAPA and customer complaint processes, ensuring regulatory compliance across FDA, ISO 13485, EU MDR, and related standards. This role coordinates cross-functional teams to drive corrective actions and maintain QMS metrics.
The position requires 7+ years in medical devices or biotech with CAPA/complaint focus, strong leadership, and expertise in eQMS systems such as Track Wise or Master Control.
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