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Katalyst CRO

QMS Audit Readiness Lead for Medical Devices

austin, TX

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Job description

Katalyst CRO is seeking a QMS Consultant to plan, scope, and lead mock audits ensuring readiness for a BSI notified body audit. You will evaluate the QMS against ISO 13485:2016 and EU MDR 2017/745, ensuring risk-based compliance and effective stakeholder communication.

Role requires in-depth knowledge of medical device QMS, effective reporting, and strong cooperation with leadership to address gaps before a live audit.

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Worksite address

austin, TX, 78716, US

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