Katherin Mendoza Sotomayor

• Spearheaded analysis and evaluation of suppliers, guaranteeing compliance with Abbott's corporate requirements and BMP standards.
• Managed Change Controls and Non-conformities
• Executed contract addendums according to corporate specifications
• Conducted supplier audits to ensure compliance with agreements
• Led and participated in internal audits as Lead Auditor and Internal Auditor

Delivered notable enhancements in TTC metrics.

• Efficiently executed the Change of Provider Notifications process, ensuring compliance with corporate policies and producing accurate global and regional reports.

• Spearheaded the enforcement of Quality Management as well as monitoring adherence to good storage, distribution, and transportation practices
• Successfully utilized Six Sigma techniques to improve process efficiency, leading to enhanced dispatch timelines and inventory optimization
• Managed the implementation of Technovigilance Best Practices processes, validated said processes, and provided weekly KPI reports to management
• Achieved a high success rate in obtaining health registrations by effectively completing dossier preparation tasks.
• Ensured effective representation of the company in inspections carried out by DIGEMID and other institutions.
• Performed audits on internal processes as well as suppliers' operations in BPM, BPA, BPDT, and ISO 9001.
• Oversaw the management of regulated and hazardous waste, in addition to inventory management and quality control for both imported products and raw materials.
• Attained BPA recertification along with BPDT certification
• Drove improvements in processes that led to reduced waste and improved financial performance.
• Maintained a high level of Claims Resolution, with a success rate of 99%.
• Successfully obtained ISO9001 homologation from SGS.
• Achieved the implementation of a robust Management System for the import and sale of refrigerated products, ensuring full compliance with relevant regulations

• Achieved compliance with legal regulations through the implementation of Good Storage Practices, effective document management, and preparation of Dossier for Class I, II, and III Medical Devices.
• Oversaw the compilation of documents for procurement procedures
• Established relationships with vendors and suppliers to secure favorable terms for materials or services.
• Identified opportunities for improvement in operational performance metrics.
• Recruited, trained, supervised, evaluated and mentored staff members.

• Successfully implemented a Quality Management System following BPA, BPM, and ISO 9001 guidelines. Additionally handled the preparation of Dossiers needed to secure Sanitary Registrations.
• Prepared records for government procurement.
• Performed evaluations on the effectiveness of the management system.
• Certified in BPM achievement.
• Executed process enhancement initiatives by conducting internal audits
• Provided coaching and mentoring to team members on a regular basis.

• Realice la Implementación de Buenas Prácticas de Almacenamiento, gestionar el Almacén de los productos regulados
• Logré una correcta gestión de Stock y Rotación de productos e inventarios de Almacén
• Responsable de las auditorías internas BPA

• Estuve a cargo del Sistema de Gestión de la Calidad de la Clinica, asimismo la gestión del almacén
• Logré un mapeo de todos los procedimientos de la clínica para implementar el Sistema de Gestión de la Calidad
• Logré realizar el Plan de Manejo de Residuos Peligrosos de la Clinica

• Estuve a cargo del análisis de las muestras que proceso el Laboratorio de Criminalística, las misma que provenían del Ministerio Publico Logré la actualización de Procedimientos Operativos Estándares del Laboratorios, el adecuado manejo de Equipos de Cromatografía de Papel, Gases y Absorción Atómica
• Logré la actualización de técnicas analíticas