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Work Background
Self-employedQuality Assurance Expert & Microbiologist
Oct. 2024
Boston ScientificDirector Quality Systems
Nov. 2022 - Oct. 2024Heredia, Costa RicaQuality leader for the operational processes of Boston Scientific Heredia. Management Representative and responsible for the Regulatory Compliance of the manufacturing plant before FDA, BSI, DEKRA, TÜV SÜD and other Regulatory Bodies. - Led the production ramp and launch of Pulsed Field Ablation (PFA) catheters in the US and EU, meeting all regulatory requirements and achieving stable performance with less than 3% complaints in the market. - Designed an organizational structure that allowed electrophysiology production increase by 100% with only 17% increase in staff. This achievement was based on strategic team reorganization, process optimization, and close support to key suppliers, while maintaining low turnover levels over 2 years. - Led a cross-functional team in multiple key audits, ensuring product commercialization in emerging markets and maintaining compliance in existing target markets. Thanks to effective pre-PMA audits, successful U.S. launch was enabled for cryoablation devices.
Boston Scientific en Costa RicaSr. Quality Operations Manager
Jun. 2018 - Nov. 2022Heredia, Costa RicaLeader of the quality function for the electrophysiology production units, managing the quality indicators of the business unit, support audits, budget management in alignment with Organization´s strategic plan, as well as development of preventive culture strategies through multifunctional teams. - Led 3 different Electrophysiology business units, overseeing a team of 30 people and responsible for all support activities. - Led the strategic quality planning in the Preventive Culture pillar (2019-2021), achieving, with the team, to reduce the levels of complaints in one electrophysiology product family by more than 70%. Through preventive projects focused on manufacturing, we strengthened quality risk mitigation practices in manual processes. - Main technical consultant for the establishment of a domestic sterilization facility in Costa Rica, which is set to become operational in Q1 2025, enabling the export of pre-sterilized products to global distribution centers.
STERIS CorporationSenior Quality Assurance Manager
Dec. 2008 - Jun. 2018El Coyol Free Zone, Alajuela, Costa RicaResponsible for the quality assurance of electron beam and ethylene oxide sterilization services for medical devices, in compliance with applicable international regulations. Consolidated a specialized and high-performance team. - Led the transfer of knowledge and technology for the start-up of the first contract sterilization facilities using electron beam and ethylene oxide in C.R. Serving more than 10 local/international medical device manufacturing customers. - Successfully carried out more than 60 audit processes for existing and potential customers, including FDA, TÜV and BSI, as well as key suppliers. Ensuring compliance with international regulations such as EUMDR. - Designed and implemented the internal microbiology laboratory for control of sterilization processes, generating a reduction in response times and costs for customers. - Developed and managed the supply chain of raw materials, services and critical infrastructure, ensuring operational continuity, expansion of services and anticipating the needs of current and future customers.
AllerganMicro Lab Supervisor
Jun. 2008 - Dec. 2008Global Park, Heredia, Costa RicaAccountable for the recertification of cleanrooms, bioburden and LAL testing that supported the manufacture of medical devices in compliance with safety / sterility requirements.
Kraft FoodsMicro Lab Supervisor
Oct. 2005 - Jun. 2008La Ribera de Belen, Costa RicaResponsible for the supervision of Microbiology and physicochemical laboratories for the control of raw material, in process and finished products. Part of the cross-functional team oriented towards ISO 9001:2000 recertification as well as the initial ISO 14000 certification. Optimized processes and increased competitiveness by accessing regulated markets.
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