Medical Device Quality Engineer | ISO 13485, FDA, Relocation

HotRun Inc. is seeking an experienced Quality Engineer to support a global medical devices supplier near Dallas, TX.

The role focuses on quality processes, audits, CAPA, training, and laboratory functions in line with FDA 21 CFR 820, FSSC22000, and ISO 13485:2016. Responsibilities include integrating quality systems across North American plants, enabling quality tools for manufacturing evaluation, and maintaining ISO 8 cleanroom operations.