Global Quality Manager - New Product Introduction (NPI) Focus Quality Planning & Strategy: Lead the design and deployment of Quality Management Systems (QMS) processes and tools to ensure NPI objectives and customer requirements are met. DFx & Technical Readiness: Drive Design for Excellence (DFx) reviews and oversight on validation strategies (IQ,OQ,PQ) to ensure seamless product transitions from design to mass production. Launch Readiness: Manage launch readiness assessments, Monthly Operations Reviews, and Customer Satisfaction Surveys to ensure operational excellence at the HealthTech sites. Regulatory Oversight: Ensure site-wide conformance to international regulations and customer certifications (e.G., ISO 13485, ANSI/ESD ). Performance Monitoring: Analyze data from customer scorecards, regulatory audits, and operational performance to identify gaps and communicate action plans to stakeholders. Global QMS process ownership: Develop and support key QMS processes to ensure regulatory compliance and mitigate operational risks. Process Deployment:



Document and deploy integral quality processes (Audit Compliance, Customer Feedback) in alignment with strategic corporate initiatives. Training & Capability Building: Educate sites on global procedures to build independent, high-functioning quality teams capable of maintaining long-term quality initiatives. Quality Frameworks: Expert-level knowledge of ISO 13485, 21 CFR 820 (QMSR) and ANSI/ISO/ESD standards. NPI Quality Planning: Deep proficiency in defining critical quality business processes, tools, and system applications required to meet site-level and customer-specific quality objectives. Advanced Quality Tools: Mastery of core quality methodologies, including FMEA (Failure Mode and Effects Analysis), 8D Methodology, Change Control Board (CCB) protocols, and Manufacturing Quality Standards (MQS). Validation & DFx: Technical understanding of validation strategies (IQ/OQ/PQ) and Design for Excellence (DFx) to ensure se

📌 Global Quality Leader (Alboraya)
🏢 Celestica
📍 Alboraya