·        Serve as PMIT Issue Manager for a pre-market diagnostics program, leading issue tracking, investigation, and resolution to support product development and regulatory readiness.

·        Manage PMIT records and Non-Conforming Material Reports (NCMRs) with Engineering, Manufacturing, Supplier Quality, and PMO teams to drive root cause analysis and corrective action.

·        Support production quality for commercialized diagnostic platforms, reviewing and approving quality documentation, deviations, and change controls.

·        Partner with cross-functional Manufacturing, Engineering, and Regulatory Affairs teams to investigate quality issues and implement CAPAs.

·        Support Material Review Board (MRB) activities and disposition of nonconforming materials to minimize production impact while maintaining compliance.

·        Maintain and support the Quality Management System (QMS) in alignment with FDA regulations, GMP requirements, and ISO 13485 standards, contributing to audit and inspection readiness.

·        Support internal audits and external audits to help ensure Quality Management System (QMS) effectiveness and ongoing compliance with established quality requirements.

·        Support validation activities and regulatory inspections in alignment with FDA regulations, GMP requirements, ISO 13485 standards, and applicable product quality requirements.

·        Work with Manufacturing, Engineering, Quality Operations, and Regulatory Affairs to ensure Alinity i and ACP manufacturing processes consistently meet product specifications, quality requirements, and applicable regulatory standards.