Naudy De Leon Taveras Email & Phone Number

Dominican Republic

Manage the risk(s) associated with quality concerns. Provide input into and manage the department's budget, department strategic plans and quality plans. Functional level support QA team ensuring that rigorous root cause analyses have been initiated and/or completed. Recommend and coordinate cross functional and/or organizational support to resolve an issue. Promote a diverse and inclusive work environment where my team feels supported and openly communicates opportunities and issues knowing they share a feeling of mutual trust Contribute to the successful attainment of the company's quality Key Performance Indicators and journey to differentiated quality. Champion the development of and deployment of the systems and tools to drive innovation and Ensure that the investigation and disposition of non-conforming materials meet all necessary internal and customer requirements and assure efficacy of corrective actions to prevent recurrence. Lead and manage product complaint investigations. Initiate and facilitate plant CAPA activities that result from the analysis of data from complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis. Provide support of Integer's Strategic Imperatives: Embrace the Manufacturing Excellence culture based on the Integer Production System and its five focus areas: Support strategy alignment through Site Hoshin Plans, quality planning meetings, as Quality representative at site Plant Leadership team meetings, and through site all-hands communication meetings. Leadership of Sustained Change by identifying opportunities to continuously improve our processes and products and ensuring implementation of such changes comply with all customer contractual obligations and regulatory requirements.

Dominican Republic

Oversee the quality system metrics and data, to provide work direction for Quality Supervisors, Quality Technicians and Quality Inspectors to support and maintain quality management system, risk management and quality control plans. Responsible to manage personnel within the following areas: Quality Engineering, Quality Operations, Quality Projects, Continuos Process Improvement and Incoming Inspection. Collaborate in the process design and design transfer activities ensuring that adequate systems are properly validated and qualified to ensure to meet product requirements.Other functions executed are:-Supervise and mentor quality operations engineers and technicians.-Collaborate with multidisciplinary teams to conduct investigations of non-conformances and recommend corrective and preventive actions, audits, validations and in process changes.-Promote multifunctional team approach and the company's cultural beliefs while ensuring that expected project output meet the Quality System requirements.-Responsible for leading multifunctional teams to develop the quality planning through risk assessment activities, creating and maintaining files including Process Map, FMEA and others applicable documents.-Ensuring that direct reports are appropriately trained for their respective job functions-Review the adequacy and correctness of PMAPs, FMEAs, Control Plans, AQP, validations (protocols and reports), documentation changes and non-conformance investigations.-Lead and support in continuous improvement projects.-Organizes QA resource assigned to functional area to meet goals and timings; coordinates prioritization of activities with area's Senior Management.

Dominican Republic

Lead the Department of Quality Engineering Investigations of complaints, CAPAs and non-conformities for key customers.Identify, lead and actively participate in cost saving and compliance projects of high impact with the objective of improving quality and reducing costs.Serve as a technical consultant related to quality issues for key customersReport to the senior management the results of evaluations and management effectiveness of the Quality System.PMO of the Quality Operations improvement project portfoliosManage quality and process improvement complex projects (Kaizen/Six Sigma)Over 300k US$ in cost saving due to quality improvement projects implemented

Dominican Republic

- Support the development, qualification, and implementation of inspection, test, and measuring equipment- Lead cross-functional team to write Process Failure Mode Effect Analysis (PFMEA), Process Control Plans (PCP) and Device Master Records (DMR)- Write, review and/or approve process and product validation protocols, procedures and reports, equipment qualifications, engineering change orders for NPI and Sustaining Projects-Develop and execute software validation protocols-Provide technical support (subject matter expert) during audits (internal and third-party audits).- Develop and establish effective quality control and associated risk management plans- Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate- Manage and supervise the calibrations system - Ensure compliance with the requirements associated with standards and regulations applicable to the plant in accordance with the quality manual related to product transfer, quality planning, risk management, change control, improvement or changes to current processes- Provide support to Design Quality, MPD and RDE projects ensuring compliance of QSM requirements- Develop and execute Test Method Validations protocols and implementations- Support compliance with both organizational objectives and relevant regulatory requirements including US FDA Quality System Regulation (QSR)/Good Manufacturing Practices (GMP), ISO 13485, European Medical Device Directive (MDD), European Union Medical Device Regulation of 2017 (EU MDR)

Dominican Republic

- Lead and support team efforts to improve the quality management system (QMS) and manufacturing process- Develop, improve and maintain quality standards for the manufacturing process.- Develop, improve and maintain test and inspection procedures- Collaborate with engineering and manufacturing to ensure that quality standards had been implemented- Develop and implement test and inspection methods.- Develop and implement sampling plan for product acceptance- Approve validation protocols and reports according to QMS requirements- Analyze problems reported and develop improvements to mitigate or eliminate them- Develop and implement projects to improve process related to CAPA and Complaints Systems.- Ensure that process controls had been implemented prior new products commercialization- Ensure compliance with the requirements associated with standards and regulations applicable to the plant in accordance with the quality manual related to product transfer, quality planning, risk management, change control, improvement or changes to current processes.

Dominican Republic

• Lead and support team efforts to improve the Quality Management System (QMS) and manufacturing processes• Develop, improve and maintain quality standards for manufacturing process• Develop, improve and maintain procedures and methods of testing andinspection• Collaborate with Engineering and Manufacturing to ensure that Quality standards are implemented and maintained• Create and implement test and inspection methods• Develop acceptance sampling plans• Qualify test equipment for inspection and label printing• Approval of validation protocols and reports• Lead and support investigations of failures, ensuring that the systematic methods of problem solving are being employed and properly documented• Monitor compliance with regulatory requirements and the company• Ensure that controls have been implemented prior to the marketing of new products.• Document OEM Corrective Action Requests (SCARs)• Monitor the effectiveness of the Quality Control Plan.• Identify and implement projects to improve processes and qualityof the products.

Dominican Republic

-Test current products and identifying deficiencies-Suggest solutions to identified product -problems -Investigate product quality in order to make improvements to achieve better customer satisfaction-Plan, create and manage the overall Quality -Planning strategy-Collaborate with the Product Development team to ensure consistent project execution-Identify quality assurance process bottleneck and suggest actions for improvement -Oversee continuous improvement projects -Collect quality data -Identify key KPIs for product quality-Prepare and present reports and metrics to Senior Management

Dominican Republic

• Identify manufacturing issues, create problem reports, and follow up with Manufacturing for resolution.• Recommend process improvements to achieve cost effectiveness and improved product quality.• Assist the manufacturing operation in problem solving in order to meet product requirements. • Collaborate with development and QA teams to maintain high-quality of the product during its evolution and design change. • Provide technical training and product overview (Final Packaging Area).• Collect data and create charts to identify the top offender defects and their root causes. • Perform GR&R and CPK analysis to validate and analyze measurement processes.• Conduct audits to confirm if MWIs, PCPs and CTQs are being followed up and completed as intended.

Farmingdale, New York

Applied engineering principles to develop and operate electrical, mechanical and data processing systems.Inspected precision machine parts using micrometers, height gauges and optical comparators.Ran operational tests on systems and equipment to reinforce proper processes and remedy malfunctions.Reviewed work orders and communicated with prior shift to assess work needs for the day.Increased laser marking production time and quality by updating and optimizing the laser marking software linearprogramming structure.

Officiate intramural games.Assist in set-up and break down of all fields and courts.Enforce rules and maintaining the code of conducts expected amongst Intramural participants.Ensure that all equipment has been put away neatly and all score-sheets have been returned to the Campus Recreation office.

Consuelo, Dominican Republic

Ensured the correct functioning of all the electrical equipment and components in factoryMonitored production of productsRepaired and install electrical motors and pumpsPerformed maintenance on sensors and metering devicesDesigned maintenance plan for better efficiency of the factoryCompleted and submitted necessary reports

San Pedro De Macoris, Dominican Republic

Taught English to high school English language learners Planned lessons, taught classes and graded student work Evaluated students to comply with norms established by the Dominican Republic Secretary of EducationSpoke with parents and students to discuss and enhance student progress

Bachelor Of Science (Bs), Automotive Management Technology

Activities and Societies: Latin American Students Organization, Farmingdale State College Radio Station, Collegiate Science and Technology.

Bachelor Of Engineering (B.Eng.), Electromechanical Engineering

Activities and Societies: Electromechanical Engineering Board of Students, Digital Electronics tutor.Digital Electronics tutor. Board.