Quality Manager

• Aug 2019 - Present

Quality Assurance Senior Manager

• Apr 2013 - Aug 2019

CREGANNA MEDICAL (Medical Devices Industry, OEM) Provide leadership, expertise, direction and guidance. Plan, develop and monitor PWC Quality Management System to ensure that all Quality objectives are met as well as the Operational, Process Improvement and Product Development & Transfer processes/projects are implemented in an efficient and effective manner. Responsible for providing support and communication with PWC Operations group and costumers to resolve design issues and other related product concerns. • Ensures FDA QSR (GMP), ISO 13485, MDD, CMDCAS and/or other national or international standards are continuously met. Develop and implement compliant processes across the company • Ensure that a document control procedure is adopted to approve, review and update all changes to critical documents within the scope of the QMS. • Ensure that records are established and maintained to provide evidence that the QMS is being followed and that there is a system in place for the identification, storage, protection, retrieval, retention time and disposition of such records. • Ensure that the performance of the QMS is reviewed at planned intervals to ensure its continuing suitability, adequacy and effectiveness. This review means assessing opportunities for improvement and the need for changes to the QMS. • Ensure that Quality Objectives are set by top management for measuring the performance of the QMS and that these are regularly reviewed. • Ensure that all suppliers used by the organization are selected, evaluated and reevaluated and that records of this assessment are maintained. • Ensure that top management undertakes periodic but regular assessments of customer satisfaction and that consequent improvements are identified and implemented. • Ensure that an internal audit program is adopted to verify that the QMS conforms to planned arrangements, QMS arrangements and is effectively implemented and maintained. Show less

Quality Assurance Senior Manager

• 2011 - Mar 2013

• Direct and supervise the inspection of components and their proper disposal, developing relationships with suppliers, and sterilization process release and environmental control of clean rooms and associated areas based on corporate procedures established by the company and good manufacturing practices dictated by industry, to ensure the quality of components used in the preparation of the final product, the product sterility of the product and environmental quality in Clean Rooms.

Incoming Quality Manager

• 2004 - 2011

• Develop suppliers audits to local and external suppliers. • Coordinate with suppliers, improvements in the components based on company needs to upgrade the product quality.• Management of corrective actions provided by the suppliers.• Suppliers Evaluations.• New vendors development.• Assessment and maintenance of components at different scales of inspection.• Coordination of MRB (returned product location / standby).• Control and Coordination of Non Conformities Reports and Deviations.• Incoming Quality Department Activities Supervision.• Develop training for IQA Department • Coordinate programs to improve efficiency of the Incoming Inspection area, in order to improve the performance not only in the area, but the company.• Active Participation in processes both internal and external audits. •Monitor the development of first articles inspections for new components, change of revisions and fixtures, to ensure compliance with the specifications given by the company. Show less

Customer Service Chief

• 1999 - 2004

• As part of my duties, I built from the ground up the Customer Service Department, which allowed the company to give the best fertilizer delivery service in the country, being this at the same time a major pillar in the market substitution that the company achieved. • Elaborated and implemented in a task force among with other area chiefs, the programming procedures, billing logistics and product delivery and callback for an annual movement of 245 thousand MT in Costa Rica, Nicaragua and Panama. • Elaborated and implemented the production and distribution procedures for supermarket fertilizer delivery, agrichemicals distribution and liquid fertilizer formulations operation logistics. • Was an active participant on the foundation of the Environment Management System that ended on the certification of company under ISO 14001 (first fertilizer company in Latin America ever). This as an internal auditor and as responsible for training and formation. Show less