Responsible for Quality Dept. (QA Engineers, technicians, and specialists). Ensure G&O are completed as planed and development plans are in place for direct reports and QA dept. employees. Ensure Quality systems are in control and complying with company goals. Host external/corporate/internal audits as needed. Perform procedure upgrades as required as part of the continues improvement culture. Develop, monitor, and control site metrics. Responsible for site Quality Management System (QMS). Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets. Promotes awareness of regulatory requirements throughout the organization. Responsible of Incoming Inspection, Final Release inspection, CER Environmental Monitoring execution, address properly sterilization issues, and site supplier process.

Assure NC’s metric complies with goals established. Managing QC resources as required (work balance, project assignments, activities completion, etc.). Lead QC Techs team, determine G&O and perform development plans for this personnel. Participate as auditor for internal audits and participate int the back room for external/corporate audits as required. Address non-conformance, CAPA’s, and audit observations properly. Ensure Environmental Monitoring is performed properly and on time every quarter for our Class 8 Clean Room. Acting based on a continuous improvement culture. Lead with example on a high-quality level culture. Address Human Resources cases/issues as required. Escalate issues as appropriate with management and to a higher level in the organization. Identify training and education needs to accelerate learning and achieve results based on goals. Create a training plan/development plan for the team according to departmental needs.

Assure departmental metrics comply with goals established. Managing resources as required (work balance, project assignments, activities completion, etc.). Lead FAL analyst teams in Juarez, MX and Santa Clara, CA, USA. Establish G&O for engineers and technicians and perform development plans for personnel. Participate as auditor for internal audits and as a back room lead for external/corporate audits. Address non-conformance, CAPA’s, and audit observations properly. Acting based on a continuous improvement culture. Lead with example on a high-quality level culture. Address Human Resources cases/issues as required. Escalate issues as appropriate with management and to a higher level in the organization. Identify training and education needs to accelerate learning and achieve results based on goals. Create a training plan/development plan for the team according to departmental needs.

Assure departmental metrics are in compliance. Address any non-conformance, CAPA’s, audit observations to make sure corrective/preventive actions are well determined and properly implemented. Provide support during internal/external audits on any requirement related to complaints department. Establish goals and objectives for engineers and technicians and perform development plans for them in order to keep and develop talent within the organization. Maintain people engagement through motivation, continuous learning, empowerment and recognition to the team. Detect, analyze and determine process improvement opportunities on internal/external processes and procedures. Lead with example on a high quality level culture. Lead FAL analyst teams in Juarez, MX and Santa Clara, CA, USA. Maintain communication with different sites and organizations to assure a process flawless during customer complaints process. Provide customer service.

Support on New product lunching from Quality perspective. Work instructions development, Test methods validations, Control plan, MQP's (Process flow charts), pFMEA's revision, SPC Implementation, Quality Standards (visual aids), and other documentation related according to applicable regulations. Approver of validation documentation changes and participant in other QA internal initiatives. Quality non conformances investigation, documentation, and revision.

Responsible for providing support on New product introduction for Cummins and GM customers from Quality perspective. Work instructions development, Test methods, Control plan, and documentation related according to regulations related.

Responsible to complete on time any assigned project related to Quality Assurance following applicable regulations and procedures. (PFMEA's revision/creation, Sampling Plan revisions, CAPA's actions, Non conformances investigations, QA Metrics, QA Projects, etc.)

In charge of the Master Training plan for ME2 initiative. Responsible of the New Hire Orientation Program and other trainings. Support as trainer if was needed. Supervisor of all trainers and trainer leaders and responsible (40 people) to complete all trainings of wage personnel for Cordis. Also responsible to complete and implement the Master training Plan for AAA product during its transfer and responsible to deliver the metrics regarding the training department. Evaluating and creating development plans for trainers.Responsible of implementation and creation along with the engineering team the training plan for OpCert Program (program that involves a certification for people that develop inspection operations). Administrator of Compliance Wire System (create quizzes and training curriculums, CURT’s assigner, revision of the employee’s training history -compliance-, etc). Trainer of all selected wage personnel to be certified in this program for Campus Juarez (Companies: Cordis, Biosense Webster, and Codman).

Responsible of Product Configuration (PC) in JDE System updating the system of all engineering changes requested such as the BOM, parts, specs, flows in router sheets, etc. Instructor of trainings in the use of JDE System for approvers, users, and processors. Support in other activities related to Documentation Control Dept. as needed. Participate in activities related to the quality importance such as Do it Right Initiative in the change of management Pillar.

Responsible for the scanning of all documentation such as CAF’s, engineering studies, capability studies, Protocols, DHR’s, etc. Also responsible of approval and revision of all changes made in the documentation (CAF issuer). Support in audits (internal and external) was provided as needed as runner. Maintain organization and control of the EES documentation. Offer a good quality service to the customers in order to get their satisfaction in such service.