Process Validation Requirements and Compliance Strategies

José Mora

Medical Device Quality Systems & Configuration Management Consultant

José Ignacio Mora is a Principal Consultant specializing in Manufacturing Engineering, Quality Systems, Design Controls, and Configuration Management within the medical device industry. For more than three decades he has worked across product development, manufacturing, quality systems, process validation, supplier management, technology transfer, and regulatory compliance. His experience includes leadership positions at Boston Scientific, Stryker Orthopedics, Cordis Corporation, and multiple start-up medical device organizations. José is the creator of the Lean Documents and Lean Configuration methodology, a relationship-centric approach to managing quality system information. His work focuses on improving traceability, reducing information fragmentation, strengthening inspection readiness, and creating more effective connections between requirements, risks, verification activities, validation activities, and released product configurations. Drawing from practical experience in design controls, process validation, manufacturing systems, quality systems remediation, and organizational transformation, José provides a unique perspective on how organizations can achieve compliance while simultaneously reducing complexity and improving operational effectiveness.