I am an engineering professional who have 20 years of experience in Operations, Quality Assurance and Regulatory Affairs in the medical device industries. My first eight years of experiences were obtained in Quality Assurance at three of largest medical device manufacturer in the world and members of the 500 fortunes company (Abbott Lab, Baxter Healthcare & Cardinal Health). Developed a complete quality system for medical device manufacturers in preparation for certification in ISO13485-2003 and 2016. Achieving certification on all the systems implemented within a year time frame. The last assignment in 2016 was to coordinate a facility operations start-up and ISO13485-2016 certification, and it was accomplished in one year. The fact of being responsible for overseeing the compliance of the quality system in various medical device companies, create the opportunity to develop a great knowledge of regulatory compliance (QSR, CQSR, IS013485-2016) and vast skill in procedures development, internal audit/external audit, Supplier Quality Audits, supplier development, process and equipment validations and Design Concepts (FMEA & ISO14971) and assisted by the bilingual skills in English and Spanish. Hired as Plant Manager in 2016 to start-up the facility of Global Resources International Dominicana (GRID) with two main assignments, start operation and prepare the facility for ISO13485-2016 certification. Both tasks were achieved in one year. Contracted by DAS Medical to implement a quality system for ISO 13485-2012 certification. It was achieved in 6 months. Developed local suppliers for key material and save the company over US$250,000 per year in materials cost and transportation. Participated as a team member on a scrap and slow-moving inventory project and we save the company over 2 million dollars' worth of materials.
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