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Presentation Abstract:

Join us as he provides an overview of the essential functions of a Supplier Quality Engineer in a medical device company, covering supplier change assessments, corrective action requests, quality agreements, and more.

Speaker: Fernando Tirado, Principal Supplier Quality Engineer

Fernando Tirado is an experienced Supplier Quality Engineer with over 10 years of experience in the medical device, automotive, and aerospace industries. In his current role, he oversees supplier audits, manages supplier scorecards, supports onboarding of new suppliers, and ensures compliance with industry regulations. As a certified Lead Auditor for ISO 13485:2016, ISO 9001:2015, VDA 6.3, and IATF 16949:2016, he brings deep insights into supplier quality management and regulatory compliance.

Presentation Abstract:

The FDA is moving from the Quality System Regulation (QSR) to the new Quality Management
System Regulation (QMSR), aligning more closely with ISO 13485 standards. Whether your
organization is already ISO-certified or not, it’s vital to adjust the QMS to meet 2026
Compliance deadline. This session will provide a comprehensive overview of key components
of the QMSR, highlight critical updates from QSR and difference from ISO 13485, and share
best practices for achieving compliance.

Speaker: Yuan Xu, Director of Quality and Regulatory at Vivalink

Solution-Driven QARA Consultant with a specialized focus on QMS and GxP Compliance for Medical Device/IVD/Biotech industries. 10+ experience of End-to End Quality lifecycle support, from Design Control, Clinical Study, Product Launch to Post-market Quality. Proven track record in strategic planning, QMS building, Regulatory Inspection to ensure adherence to ISO 13485, 21 CFR 210/211, 820, MDSAP, ICH and EU Regulations. Yuan currently hold certifications of ISO Lead Auditor, ASQ- Six Sigma Black Belt, CQE, CQA, and RAPS-RAC.

Presentation Abstract:

This is an introduction to attribute data analysis.  Binomial distribution statistics are presented with incoming inspection applications including the use of OC (Operating Characteristics) curves.  Similar application to discrete statistics and probabilities are also presented using poker hand examples.

Speaker: Brijesh Patel

Brijesh Patel is a highly accomplished biomedical engineer with over 18 years of experience in the medical device industry within the United States. He brings a unique blend of technical expertise, quality assurance leadership, and project management proficiency to the table. Certified as a quality engineer, Lead Auditor (ISO 13485, 9001, 14001, 45001, etc.) and a Master Project Manager.

Presentation Abstract:

This is an introduction to attribute data analysis.  Binomial distribution statistics are presented with incoming inspection applications including the use of OC (Operating Characteristics) curves.  Similar application to discrete statistics and probabilities are also presented using poker hand examples.

Speaker: Evans Wuu

Evans Wuu is a Principal Supplier Quality Engineer at Minerva Surgical, Inc. in Santa Clara, CA. He has 40 years industry experience in Quality Assurance ranging from defense industry and medical devices, with 15 years of Medical Device startup experience.  He is ASQ CQE, CQA, and CSQP certified. His experience includes failure analysis, reliability engineering, regulatory affairs, design assurance, and operations/supplier quality.  His background includes quality engineering statistics.

Speaker: Levon Barsoumian, J.D.,

Levon Barsoumian, J.D., Principal Quality Engineer, Astera Labs. Prior to joining Astera Labs, Levon spent 7 years at Western Digital, where he managed the Platforms Products Quality Assurance Engineering team. He focused on datacenter systems, JBODs, JBOFs, and servers.