Kyrstin Mays is a Design Quality Engineer at Avalign Technologies since July 2021, where responsibilities include leading internal audits for ISO 13485 compliance, analyzing post-market surveillance data, and implementing complaint trending procedures for MDR compliance. Mays previously worked as a Quality Engineer at Zimmer Biomet, where involvement included managing Part Production Approval Process activities and supporting new product introductions. Earlier experience also includes a role as a Quality Engineer contractor focused on remediating Design History Files for compliance with FDA regulations, and a position as a Miami Beach Traffic Monitoring Consultant. Mays holds a Bachelor’s Degree in Bio-engineering and Bio-medical Engineering from Florida International University and has acquired BSI ISO 13485 Lead Auditor Certification.
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