Experienced Certified Quality Systems Professional with a successful career in FDA/ISO 13485 regulated manufacturing environments and a proven track record of maintaining a high level of Quality Compliance. A hands-on self-starter with analytical, technical, and engineering expertise combined with knowledge of FDA Quality System Regulations (QSR), European Medical Device Regulations (EU MDR 2017/745) and Directives (MDD) including ISO13485:2016 and ISO14971 standards. Effective at integrating and managing Quality Systems, with a strong focus on quality improvement, time management, and project management. Excellent oral and written technical communication skills in English and Spanish.
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medical deviceshome improvementanalysismeasurementproduct realizationresource managementmanagement responsibilityquality management systemsiso13485:2016
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