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Venova Medical, Inc.

Quality Engineer, Medical Devices & Regulatory Compliance

los gatos, CA

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Job description

Venova Medical, Inc. is seeking a Quality Engineer to own QA activities for a high-risk Class III medical device under clinical trials.

You will ensure compliance with FDA QMSR, ISO 13485/14971, and related regulations, partnering with R&D, Operations and Clinical Affairs to release safe and effective devices. Responsibilities include maintaining the quality system, conducting data analysis, leading CAPA and investigations, and supporting supplier qualification and document control in a

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Worksite address

los gatos, CA, 95032, US

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