Luis Aguado

Sr Quality Supplier Quality Engineer Manager @Ascensia Diabetes Care

Manages key contract manufacturing organizations, laboratory testing and packaging suppliers, by developing, measuring product quality and monitoring performance trends. •Actively involved in troubleshooting production issues, assessing product and process nonconformances. •Develops and oversees supplier’s laboratory and process equipment qualification activities; leads continuous improvement projects of process/product. •Manages development and maintenance of Supplier’s Quality Agreements, ensuring adherence through execution. •Assures quality systems of original equipment manufacturers, contract manufacturers and suppliers are maintained and acceptance criteria are in alignment with FDA 21 CFR 820/803, ISO 13485, ISO 9001 and MDR 2017/745 along with component/product use and customer expectations. •Works with suppliers to troubleshoot escalated complaints, ensure robust root cause analysis and effective corrective and preventive actions. •Provides quality oversight of product and process changes through review and approval of changes. •Oversight of change implementations, ensuring all deliverables (Regulatory reporting, validations) are successfully completed. •Supports external inspections and audits; Serves as an internal and supplier quality auditor, including planning, execution, reporting and closure of audits and audit findings. •Manage and maintain Intelex SCAR Database Platform and establish feedback mechanisms with Procurement, Supply Chain, Regulatory and Commercial Departments to ensure alignment in management of suppliers. •Reviews and approves document changes, including changes to laboratory test methods. Manages/leads the Special Manufacturing Orders Process (SMO) and Liaised with Manufacturing/Sustaining Engineering, Product Management, Risk Management and Regulatory Departments to get them approved. SMOs are Deviations that are extended to Original Equipment and Contract Manufacturers and Suppliers to build product.