Dennisse Calderón

Design Assurance representative on cross-functional teams per ISO 13485, EU MDR, and FDA 21 CFR 820.30. Reviewed DHF documentation (design inputs/outputs, V&V, risk files), led design change assessments, and executed risk management (ISO 14971/DFMEA). Led Design Transfer for Interventional Cardiology products and EU MDR compliance across multiple products — zero nonconformities, on schedule.

Architected and deployed a global CAPA program across 8+ international sites, establishing the first standardized CAPA governance framework (FDA, EU MDR, TGA, MHRA). Trained 1,000+ employees globally on 8D/RCA methodology. Served as Global CAPA SME during FDA, TGA, BSI, and Notified Body inspections achieving zero critical findings. Managed CAPAs end-to-end in MasterControl eQMS; delivered executive KPI dashboards and facilitated global CAPA Review Board meetings.

Qualified 60+ suppliers (mechanical, plastic, electronic, packaging) per ISO 13485, FDA 21 CFR 820, and EU MDR. Managed NCMRs/SCARs end-to-end; executed IQ/OQ/PQ validations and FAI reviews. Performed 80+ supplier audits and led risk assessments for critical/single-source components. Collaborated in Early Supplier Involvement (ESI) for NPI and developed Supplier Quality Agreements and scorecards.

Supported supplier selection and technical qualification for NPI programs. Led Early Supplier Involvement (ESI) in design reviews and advised on DFM. Reviewed supplier Control Plans, PFMEAs, and FAIRs across metals, polymers, machined, and packaging categories including RoHS/REACH/biocompatibility assessments. Collaborated with R&D to develop and validate test methods per applicable standards.

Managed global RFQ/RFP processes, supplier evaluation, contract negotiations, and SAP-based procurement for medical device components and services. Developed strategic sourcing strategies, monitored budgets, and identified cost-reduction opportunities. Collaborated with Supplier Quality, Legal, and Finance on contract terms, quality clauses, and SLAs to optimize TCO and ensure regulatory compliance.