Director and Site Management Representative in charge of the Quality Organization for the Structural Heart Business Unit (BU) at Abbott Costa Rica. Process owner at BU level for Production and Process Controls.

Senior Leader and Site Management Representative in charge of the Quality Organization for the Structural Heart Business Unit at Abbott Costa Rica.

Multiple Quality Management roles occupied at St. Jude Medical facility (currently Abbott). Refer to previous roles listed below.

Acted as Site Management Representative in the absence of a Quality Director for over a year.Led the Process and Product Quality function for Tissue Heart Valve manufacture, and the Supplier Assurance and Receiving Inspection functions for the site.Established the business structure and successfully implemented direct purchasing and full receiving inspection of components for fractional flow reserve technology products and vascular closure devices during 2014. Experienced professional that provides key support to successful FDA inspections and external Notified Body audits.Quality leader responsible for the New Product Introductions to the Costa Rica site, including responsibilities for quality planning, quality personnel training, validation strategy definition and execution, all in order to support a successful regulatory approval. Four projects already completed and actively managing other four projects. Also, in charge of the Process and Product Quality function for the new manufacturing business area, with products that range from structural heart implants to atrial fibrillation diagnostic and irrigated ablation therapy catheters, among others.

Manager in charge of the Quality Organization during the startup of the SJM Costa Rica facility, the integration of the site to the divisional Quality System and the transfer of the Tissue Heart Valve manufacture, with direct oversight of all functions including Process/Product Quality, Analytical and Microbiology Laboratories, Calibrations, Receiving Inspection, Supplier Quality, Documentation Control, Quality Systems and other responsibilities such as ensuring budgeting, staffing and capital equipment readiness.

Quality Manager in charge of Validations, Biochemistry (Microbiology) Lab and Calibrations for the Costa Rica site.

Selected as the candidate for the Quality Leadership Enrichment Program. He relocated to the United States of America for a period of 9 months. Responsible for identifying and executing growth/development programs with Corporate Device Quality Operations and Regulatory Affairs. Responsibilities included leading roles with programs and initiatives such as device product development process improvement, consolidating opportunities of Registered Certified Bodies for international markets, becoming trainer of Device Design Controls, among others. This position reported into the Vice President of Device Quality Operations (Senior Staff/Executive Management).

Technical Services Manager-Validations-Calibrations-Biological Lab (Micro)Regulatory Compliance Manager-Compliance Auditing (Internal and External)-Documentation Control-Final Release and Batch ReviewQuality Engineering/Investigations Manager-Investigations-CAPA-Risk Management-Customer Complaints

Leader of the Customer Complaint Handling system and supervisor of two QE Technicians for Hospira Costa Rica. Responsible for the application of all quality tools and techniques necessary to solve quality problems and/or investigations in a team work environment. This includes managing the investigation process for non-conformities at plant level, writing down exception reports, while ensuring proper risk management and product impact.Position held at Abbott Laboratories, which then became Hospira.

Responsible for the excursion management system, containment, risk assessment and disposition of non-conforming material (DRB/MRB, disposition and material review boards). Also in charge of several improvement projects to the manufacturing process.