.**_Quality Engineering manages product and service quality planning, evaluation and control. This job family works cross-functionally in the development and implementation of prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services._****_ Main Responsibilities _**- Act as regulatory expert for the functional teams in the execution of change management and validations activities for products, process, materials and software.- Support and guide from the QA Engineering perspective all activities related with projects that impact the facility, the product and the manufacturing operation (VIPs, cost saving, continues improvement)- Lead the Risk Management Process for the manufacturing site and products under responsibility. Ensure decision-making based on risk for the process and products- Support and guide the team in product and process investigations arising from manufacturing, processes, facilities, suppliers, materials, as well as complaints and nonconformities of audits and inspections- Direct responsible for the handling of the non-conforming product and the entire process to be followed for the adequate disposal and retention based on the applicable procedures and regulations- Support and direction in transfer projects and new products to ensure in compliance and effectiveness during the execution- Assess trends in products and processes to active the corrective and preventive actions when it is applicable. As well, the development of plans as part of the continuous improvement.- Ensures all processes and procedures developed and under their responsibility comply with the quality system, corporate policies, regulations, and any other applicable requirements.- Ensures projects are completed on time and within budget- Assists the quality research and development team in ensuring proper implementations in the applicable process and products- Assists the Site Quality Manager with the Product Corporate Holds and all the activities and information required for the distributed product analysis- Development and management of quality engineers to ensure compliance with activities, their knowledge and growth.- Lead the continuous improvement projects of the department focused on the quality of the product, the patient the efficiency and cost