Quality Engineer Ii

**Our team wouldn't be the same without your enthusiasm for collaborating**Collaboration stimulates you to think big and awakens the best in the people you worked with. You are a person open to different perspectives and you are helping to turn them into robust solutions. We value your ability to work with people who have different points of view to come up with solutions that are understood and respected. You will be of great help to our workplace.You’re not the person who will settle for just any role. Neither are we. Because we’re out to create Better Care for a Better World, and that takes a certain kind of person and teams who care about making a difference. Here, you’ll bring your professional expertise, talent, and drive to building and managing our portfolio of iconic, ground-breaking brands. In this role, you’ll help us deliver better care for billions of people around the world. **It starts with** **YOU**.****In this role, you will**:- Review and approve validation protocols for new and existing equipment through the use of approved procedures to ensure their quality; Participate in the planned inspections and investigations of accident incidents for the EHS system.; Follow the requirements of the environmental policy- Assisting the Manager of Quality Assurance in the planning, organization of the activities and work carried out in the quality department, such as the systems put into practice and maintaining the standards according to the FDA and the GMP for the quality and conformation of the product.- Contribute by ensuring the maintenance of the required certifications, ensuring the availability of the product in the global market. This includes ISO 13485 and EN46002.- Review, verify, develop and validate the test methods for products and / or processes by using applicable procedures to ensure that they meet the established requirements.- Handle, execute and control the calibration and test equipment based on the requirements to ensure that the tests are performed with reliable measurements based on the standards.- Contribute in the process of corrective actions from its beginning to its completion based on the procedures established to ensure compliance; Contribute to the investigation of the client's claims through the use of the claims system established for the generation of the RCA and AP, as well as contributing to maintain the responses to customers in a timely manner.- Develop and maintain the controlled environment in all the required process areas through the control processes of bacteria, pests, positive pressure, hygiene, etc; Comply with all security requirements that have been established as well as active participation in all development and monitoring activities of the EHS system.- Analyze the necessary statistics to be able to monitor the non-conforming product, the DPM of receipt, process and packaging with trends that allow us to determine its capacity.- Ensure compliance with the requirements of quality standards and regulations (ISO-13485, FDA / GMP, and others applicable), in accordance with established policies and procedures.- Lead the quality engineering group to ensure compliance with applicable validation requirements; Lead the quality engineering group to ensure follow-up to our product specifications following the applicable methods; Support the quality engineering team and processes to improve inspections in process and design sampling plans required in special cases; Provide the necessary training to all the personnel involved, maintain the training needs system of the Quality DepartmentKey Relationships / Customer Expectations:- With Manufacturing Engineers or Processes to share, verify and decide the activities generated from corrective actions, complement the process inspection activities.- With the logistics department to verify the processes of receipt inspection, management of the retention area and good management, identification and approval of the chemicals used in the process. With the mechanical maintenance department to efficiently run the calibration process of the measurement and test equipment, to report machinery failures in the process, to require compliance with the equipment maintenance.- With the change control committee to participate in all the changes of processes or machinery that are carried out in the plant. Decide if it is necessary to validate or not, and check that the quality requirements are met.External Staff:- With external calibration companies, to maintain the equipment calibration system.- With fumigation companies to make the necessary fumigation programs inthe plant.- With Suppliers that affect the quality of the product. To evaluate that their products meet the established quality requirements.- With External Auditors to serve as a guide during auditing processes**About Us**At Kimberly-Clark, you’ll be part of the best teams committed to driving innovation and growth. We’re founded