Outset Medical, Inc. is seeking a Quality Systems Specialist to support and enhance the Quality Management System (QMS) globally, with emphasis on ISO-13485 and FDA 21 CFR 820 compliance. This role collaborates with Engineering, Manufacturing, and Quality teams to drive CAPA, training, and metrics.
The adecuado candidate has a Bachelor’s degree in a relevant field, 3+ years in regulated quality systems, and fluency in English. Medical device experience is preferred.
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📌 QMS Specialist: ISO/FDA Compliance & CAPA Lead (Tijuana)
🏢 Outset Medical
📍 Tijuana
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