Daniel Figueroa Email and Phone Number

•Experienced professional dedicated to directing, planning, organizing, and overseeing the management of Quality and Training activities across two facilities.• Lead local and external quality management review meetings and report and manage relevant KPIs. • Experience with ISO 13485, ISO 14971 and 21 CFR 820 with knowledge of process auditing.• Experience in FMEAs, gauge R&R / MSA, control plans, quality tools, statistical process methods, and business metrics, with a commitment to applying them to enhance and ensure quality standards• Lead quality and training teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team • Guarantee the upkeep of the Site Quality Maturity Matrix and define continuous improvement actions• Proficient Project Management skills with the capacity to effectively prioritize.

-Knowledge of medical device and governmental regulations and standards (21 CFR Part 820, ISO13485, MDR and NOM-241). -Knowledge and experience of medical device risk management standards (ISO14971).-Knowledge and experience with FDA’s product Design Control process and design/product transfers.-Experience in project management and 6 Sigma process improvement methodologies. -Experience with performing process validations (IQ/OQ/PQ), equipment qualification, and test method validations.-Experience in product design, design transfers, and production line quality standards-Experience in problem solving and quality improvement tools and techniques, including, preventative and corrective actions and how to overcome barriers to quality improvements.

o Responsible for staffing and leading product engineering team, ensuring assigned project goals and objectives are achieved o In charge of eight product engineers of different fields: product development, tooling & drawing and molding. o Investigate, propose, and manage new product development efforts or product updates.o Interface with other departments & management to communicate status of projects.o Assess equipment requirements to achieve objectives and facilitate budgetary planning.o Achieve procedures ISO/TS 16949 in design and development validation of new products

o Responsible of new projects and engineering changes o Responsible of manufacturing, validation and control of new Toyota, Honda and Volkswagen products in development process, based in a management and planning according to master schedule provided by customer.o Perform and define qualification plan and feasibility analysis according to different project needs to meet customer requirements.o Drive process, design, components and test issues to improve product quality and reduce cost o Development of PFMEA and Flow Chart for each new part number releasedo Work with external design and resources to resolve issues and ensure quality design and performance.o Supplier development and design, validation or improvement of tooling for better processo Remarkable experience in internal auditing under ISO/TS 16949 and VDA 6.3 & 6.5 standards o Solid background in process knowledge, SPC, Kaizen, PFMEA, PQCT, Quality Standards, Inspection Methods, and the PPAP process.o Perform and lead regular Lean Manufacturing workshops (5S, SMED, Poka-yoke, Reduce of MUDA)

o Manage of Forty-four quality inspectors and four leaders group to set guidance, motivation and direction to achieve the company goals regarding quality commitments to customero Monitoring and examining each stage of production to avoid quality issueso Carrying out final inspectionso Perform corrective actions to reduce Customer Complaintso Performance of inspections in accordance with process control, visual aids and instructions of the area.o Constantly participation on quality indicators and quality assurance o Control and management of non-conformance producto Validation of new productso Implementation of Kaizen ideas as creation of standards of inspections dedicated according to every customer’s needs.o Development of new procedureso Perform process audit

Management of projects of continual improvement and control of internal and external audits. Use of PFMEAS, DFMEAS, Hazard analysis and Lean Manufacturing. Supervision of quality control with the use of ECR’s, ECO’s, Failure Investigations and the use of ERP software as SAP to generate non conformances.Performed translation and correction of validation protocol documents.

Experience with sheet-metal and responsible of the production and manpower of aircraft structures related with small parts and single engine as well. Development of Method Sheets and Inspection Sheets using SAP, also the performed of tasks in quality assurance applying standards for a correct production and continual improvement process to reduce CATs and QNs.