GMI Solutions manufactures high-mix, low-volume electromechanical assemblies used in capital equipment for OEMs across the globe. Products range from small, hand-held devices to multi-ton highly complex systems for customers in a range of industries including medical, semiconductor fabrication, automation and control.Based in both the United States and China, GMI is a world class ISO 13485 certified company that is compliant to FDA Quality System Regulation (QSRs) 21 CFR 820 and CCC (China Compulsory Certification), allowing for the very highest quality while offering a fair market price.Lead the Quality activities throughout the organization to support GMI’s worldwide valuable customers.Maintain, update, and audit the Quality Management System according to ISO 13485 and FDA 21CFR820 with a continues improvement approach.

Leader in the orthodontics industry with commercial presence in over 100 countries through its subsidiaries and independent distributors networkRESPONSABILITIES:• Perform operational and compliance internal audits to subsidiaries. Audit projects encompass creating audit plans, procedures and tests to determine whether assets are adequately safeguarded and/or whether internal policies, plans, and procedures are in compliance and align to support organizational objectives fulfillment. • Execute Quality Management internal audits to confirm compliance with ISO 13485, FDA 21CFR820, and other international standards applicable to the organization.• Draw conclusions and create feasible recommendations based on the results of the audits completed.• Manage and implement special projects for Quality, Finances, Marketing, Customer Relationships, and Sales throughout the organization.

Business division of Continental AG’s rubber group -Manufacturer of tires for passenger, light truck and commercial vehicles.Responsibilities:• Defined strategies and improvement projects for the quality management area. As a result of these projects the organization reduced 10% of its scrap in terms of cost of production and its Original Equipment complaints decreased 15%• Responsible for maintaining and improving the Quality Management System (QMS) under the standards ISO 9001 and ISO TS16949• Coordinated and implemented projects related to the integration with Continental AG’s QM headquarters• Coordinated and oversaw activities of product performance test center, physical and chemical laboratory, and quality process engineering areas• Maintained and improved competence of all quality management employees by training and motivation programs

Manufacturer of kitchen and bath products, engines and power generation systems, furniture and operator of luxurious hospitality businessesRESPONSABILITIES:• Assisted in the implementation of improvement projects defined at the Global Procurement Council• Maintained and analyzed performance indicators of supply cycle processes• Prepared relevant reports for decision making• Supported the dissemination of supply management policies and procedures on the complete corporation

RESPONSABILITIES:Performed operational and financial audits throughout the entire corporation, obtaining post audit evaluations of 4.2/5.0 on average. Audit assignments included:• Created audit procedures and tests to determine whether assets are adequately safeguarded or whether policies, plans, and procedures are in compliance.• Performed thorough studies of business processes in areas under audit.• Drew conclusions and created feasible recommendations based on the results of tests performed.

Quality Management System Certification ServicesRESPONSABILITIES:Executed Quality Management System External Audits for surveillance and certification (QMS ISO 9001) in different organizations

A pioneer of shrimp production with an EMS and QMS approachRESPONSABILITIES:• Improved internal processes controls, productivity, and environmental responsibility by designing, implementing, maintaining, and auditing the company’s Quality Management (QMS ISO 9002) and Environmental Management Systems (EMS ISO 14001)• Worked as a consultant in QMS design and implementation for a flower plantation (Skyflower S.A.); and for a wholesaler/retailer (Marcimex S.A.) • Maintained competence of associates via QMS training and motivation programs

Non-profit foundation devoted to maternal and infantile medical careRESPONSABILITIES:• Designed the Quality Management System (QMS) for the organization• Started the implementation of the QMS • Trained employees involved in the QMS