CareFusionQA Manager
May. 2012 - Jan. 2015Sant Domingo, República DominicanaManagement Representative before the Quality Management System for the Santo Domingo, RD facility.
o Responsible for Regulatory Compliance of the Facility: Maintaining healthy regulatory compliance with the Quality Management System for 3 consecutive years as a management representative, through conducting internal audits, supplier management, identifying improvement opportunities and implementing effective action plans; as well as the use of quality tools whose philosophy supports the bases of the PHVA cycle (Plan, Do, Check, Act – Deming Circle)
o Lead Auditor for the RD facility, as well as Business Unit - Inter Plants : Creation and execution of programs to adapt successful management systems for audits and follow-up inspections by external organizations. Participation in successful FDA (Food and Drug Administration) inspections resulting in Zero 483.
o Responsible for the Facility's Product Quality results: Awarded as part of improvement teams for product redesign, improving product quality and efficiency.
o Implementation of the use of predictive indicators of product quality such as: First Pass Yield (FPY), Lot First Pass Yield (LFPY), among others.
o Environmental Management System Advisor - ISO 14001
Implementation of the requirements of the Environmental Management System according to ISO 14001:2001. Obtaining certification.
o Administration of the operating budget of the Quality area: Reduction of quality costs by 30% in 12 months, through the implementation of sampling plans, validation of test processes, elimination of destructive tests, consolidation of process samples and quality sampling, among other methods.