Lorena C. Email & Phone Number

Louisville, Colorado, United States

Created and managed over 100 Bills of Materials (BOMs) and product specifications, ensuring alignment with marketing strategies and customer needs for product launches.• Collaborated with marketing teams to implement successful product release strategies, directly influencing sales outcomes.• Analyzed product metadata to drive data-driven decisions, ensuring product updates met business objectives and market demands.• Led internal and external teams through critical business transitions, including acquisitions and restructures, improving efficiency and reducing downtime.• Acted as a liaison across multiple projects, ensuring synchronization between product updates and overall business objectives.• Spearheaded communication efforts across multidisciplinary teams, facilitating project completion and enhancing stakeholder satisfaction.• Validated and optimized process updates, ensuring product quality and regulatory compliance to meet global standards.• Managed the logistics and manufacturing aspects of SAP updates, improving supply chain efficiency and customer satisfaction.• Ensured all regulatory requirements, including Instructions for Use (IFUs) and translations, were aligned with regional compliance standards, enhancing market penetration.• Supported manufacturing processes through MVPs (Minimum Viable Products), improving time-to-market and customer adoption rates.• Demonstrated a customer-focused approach in driving product updates, ultimately contributing to market competitiveness and revenue growth.

Miami, Florida, United States

United States

Led validation efforts on supplier changes, ensuring all critical materials and processes met regulatory and quality standards, directly impacting product safety and marketability.• Took ownership of internal and external Corrective and Preventive Actions (CAPAs), driving process improvements and enhancing product quality.• Directed supplier selection and approval processes, ensuring business needs were met while maintaining high-quality standards and customer satisfaction.• Spearheaded cross-functional project teams, building trust and engagement to deliver high-impact results, improving customer experiences.• Significantly improved Quality Assurance metrics by closing out overdue CAPAs, reducing production delays and improving product availability.• Guided teams through regulatory and quality requirements, ensuring compliance and minimizing product recalls.• Conducted Root Cause Analysis to address production and quality issues, implementing corrective actions that improved product reliability.• Supported validation of process and material changes, enhancing manufacturing efficiency and reducing customer complaints.• Reviewed and updated Work Instructions (WIs) and Standard Operating Procedures (SOPs) for supplier management, aligning them with current business needs and improving operational efficiency.• Drove resolution of non-conformance issues from identification through closure, improving product quality and customer satisfaction.

Miami, Florida, United States

Assisted the business on the implementation of SAP by transferring and reviewing existing SCARs to SAP and guiding the suppliers through the new system.

Greater Milwaukee Area

Acted as the primary liaison between suppliers and manufacturing teams, resolving quality issues and ensuring timely delivery of high-quality products.• Built strong relationships with suppliers to drive continuous improvement, enhancing product quality and reducing customer complaints.• Managed a portfolio of suppliers, addressing non-conformances, implementing improvement programs, and supporting New Product Introduction (NPI) projects.• Conducted Root Cause Analysis to address supplier-related quality issues, implementing corrective actions that improved product reliability and customer satisfaction.• Collaborated with R&D teams on new product launches, ensuring supplier alignment with quality standards and market requirements.• Performed Product Quality Planning (PQP) and Part Approval Processes (PPAP) to ensure supplier products met industry standards and customer expectations.• Led corrective and preventive actions to address quality issues, reducing production downtime and improving product availability.• Conducted supplier audits to assess compliance with ISO 13485, driving quality improvements across the supply chain.• Played a critical role in ensuring the successful delivery of high-quality medical devices, contributing to the company's growth and customer satisfaction.

Miami/Fort Lauderdale Area

Miami, Florida

Coordinated and hosted numerous workshops and events all around Florida to aid immigrants and Mexican communities to have a better access of the services of the consulate, and professional legal advice.Fostered community relations through events such as open days and through involvement in community initiatives.