Miguel Barajas

Quality Systems Manager at Shockwave Medical Inc

Miguel Barajas has extensive experience in quality compliance and engineering roles across various companies. Miguel currently serves as the Principal Quality Compliance Specialist at Shockwave Medical, Inc., where they guide teams in defining and training core quality system processes. Prior to this, they were the Lead Complaints Specialist at Outset Medical, Inc., overseeing complaint handling and post-market surveillance activities.

Before that, Miguel worked at Jacuzzi Group Worldwide as a Senior Quality Engineer, leading the Supplier Quality Engineering group and implementing quality system processes. Miguel also held the position of Senior Quality Systems Engineer at Integer Holdings Corporation, where they managed quality systems during the transfer of manufacturing lines to a new facility.

In their earlier career, Miguel served as a Quality Systems Specialist at Medtronic, managing quality systems for medical device manufacturing. Miguel started their career as a Quality Engineer at Kyocera Communications Inc., responsible for product quality and manufacturing processes.

Throughout their career, Miguel has demonstrated expertise in audits, process improvements, and regulatory compliance. Miguel has successfully implemented quality initiatives and led cross-functional teams to achieve operational excellence.

Miguel Barajas obtained a Master of Business Administration (MBA) in Senior Management from CETYS Universidad in the year 2014. Miguel also holds a degree in Industrial Engineering with a focus on Quality Assurance from the Universidad Autónoma de Baja California, earned between 2005 and 2010. Additionally, Miguel has certifications in ISO 13485:2003 and ISO 13485:2016 Lead Auditing from BSI, obtained in 2014 and 2017 respectively. In 2023, they are expected to obtain certifications in ISO 14001:2015 Internal Auditing from BSI and EU Medical Device Regulation 2017/745 from Oriel STAT A MATRIX.

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