Irene Cocozza

I have gained considerable experience in medical devices over the past 13 years in different engineering roles. Included process support in manufacturing into the CER, sustaining, continuous improvement, cost saving projects, transfer projects, facilities and maintenance management. From February 2020 up today, I returned to my functions as Manufacturing Engineering in production sustaining, working in saving and improvement projects (reduction of scrap, standardization of methods, fixtures to improve productivity, qualification of local suppliers among others). Facilities and Maintenance Engineer as part of a cross training program since October 2018 to February 2020. Responsible of manage all the tasks related to preventive maintenance and calibration of equipment into the site, as well as the facilities maintenance required. Member of the Data Integrity team at Bayer Medical CR. Group responsible to perform data integrity assessment to the quality system and computerized systems to detect and propose remedial solutions to the gaps related to compliance with ALCOA principles. Responsible for complete structure of new SKUs (Stock Keeping Units) including BOM/PNs, LHRs, as well as labeling components (ART/PNs) containing controlled information. Performing and supporting OOTs and Deviations investigations, and CAPAs implementation. Certified by three different medical companies as Internal Auditor. Under this role I have supported the audit process performed by FDA, NSAI and TUV, with active participation in the WAR room. Continuous training for internal auditor covering topics like QMS, GxPs, DI and medical device regulations (ISO 13485, 21.CFR Part 820). Supported the transfer of Hologic's facility from Heredia to Coyol and product device assembly transfer. Responsible of layout and for enable each staff and production area including validation process. During 15 years I worked on textile companies as industrial engineer. Providing process engineering support in time studies, method improvements, layout performance, manufacturing process transfers, cost saving projects and budget control. Also on this time, I worked as Production Manager for 1 1/2 year, responsible of production supervisors, production balance and production goals. Training Process Manager responsible for the training department, coordinating the schedule for new hires, training and/or cross-training of the operators. Graduated of the University of Costa Rica in Industrial Engineering degree. Nearing completion of a master´s degree in Industrial Engineering from UCR.