Dennisse Calderón

Quality & Design Assurance representative on cross-functional med-device teams, providing compliance oversight across the full product lifecycle per ISO 13485, EU MDR, and FDA 21 CFR 820.30. Led DHF reviews, design change assessments, risk management (ISO 14971), CAPA, and post-market surveillance. Drove Design Transfer, material change projects, and EU MDR Technical Documentation updates — delivering on-schedule milestones with zero nonconformities.

Development and Implementation of CAPA Process: Designed and developed a robust CAPA process from scratch, successfully implementing it globally within the organization to enhance the capability to identify, analyze, and resolve non-conformances. Global Staff Training: Led global training initiatives for personnel on the CAPA process, ensuring comprehensive understanding and effective application of quality practices and procedures. Subject Matter Expert in CAPA: Acted as a Subject Matter Expert (SME) in

Supplier Quality Management: Ensure the quality of supplier products and processes through assessment and management according to standards and specifications. Supplier Development and Maintenance: Collaborate in developing and maintaining supplier relationships, ensuring compliance with quality requirements and regulations. Supplier and Material Non-conformity Handling: Lead the resolution of supplier and material non-conformities using CAPA methodologies, ensuring corrective actions are implemented effe

Supplier Integration in Product Development: Lead the integration of supplier capabilities and resources into the development of new products, ensuring alignment with project timelines and quality standards. Supplier Selection and Qualification: Collaborate with cross-functional teams to select and qualify suppliers based on technical capabilities, quality systems, and regulatory compliance requirements. Supplier Collaboration and Project Coordination: Work closely with suppliers to optimize component des

Supplier Relationship Management: Develop and maintain strategic relationships with global suppliers to ensure continuity of supply, negotiate favorable terms Sourcing Strategy Development: Formulate and execute sourcing strategies aligned with organizational goals, leveraging market analysis and supplier evaluations to identify opportunities for cost savings and supply chain optimization New Supplier Search and Evaluation: Proactively search for and evaluate new suppliers for direct and indirect materials,