Santiago Pache

Senior Supplier Quality Engineer Validation Sme Iso 13485 Lead Auditor Medical Device @iRhythm Technologies, Inc.

Manage supplier quality for PCBA (Printed Circuit Board Assembly) manufacturers and suppliers supporting high-volume production of the Zio® ECG wearable cardiac monitoring devices, ensuring compliance with FDA regulations, ISO 13485, and high-reliability standards.Serve as Validation Subject Matter Expert (SME), leading process and equipment validation (IQ/OQ/PQ) activities for critical electronic assemblies to maintain product reliability and patient safety.Conduct supplier qualification, on-site and remote audits, and performance monitoring of PCBA suppliers, resulting in improved quality metrics and reduced supply chain risks.Investigate and resolve supplier non-conformances, drive root cause analysis, and implement effective CAPA programs to prevent recurrence and enhance supplier performance.Collaborate with cross-functional teams (Engineering, Operations, and Regulatory) on supplier-related changes, risk assessments (ISO 14971), and continuous improvement initiatives for PCBA commodities.Support successful regulatory inspections by maintaining robust supplier documentation, traceability, and quality records for electronic components in a fast-paced, high-volume medtech environment.Leverage strong electronics background to provide technical guidance to PCBA suppliers on manufacturing processes, defect prevention, and quality system alignment.