.Engineer II - Quality Assurance EngineeringApply locations Reynosa, Mexico time type Full time posted on Posted 3 Days Ago job requisition id JR00013663Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec's revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.Convatecgroup.Com.Job SummaryKey position to support production UMD MX as main leader assuring compliance for regulations, standards, QMS internal procedures on a New Project (CCR), Process Improvements (OFI), Validation & Revalidations, Risk Management, Customer complaints investigations. In relation to quality issues from non-conforming material, maintain quality indicators and internal deviations to coordinate and perform needed activities for a good follow-up of a quality system.Duties and ResponsibilitiesProcess Control related:Assure the process control is followed during product manufacturing. Monitor the process output and organize activities to meet and maintain the product quality standards.Support the quality system by focusing on adequate handling of non-conformity activities, corrective and preventive actions.Define a classification of all Non-Conformities based upon the risk.Coordinate and lead the investigation/root cause, with the team members involved (maintenance, production, logistic, engineering, etc.).Review, update and develop procedures, instructions, quality specifications as needed.Collect and review the objective evidence to complete the investigation and therefore the correct NC closure and assure the effectiveness of the actions established.Follow up the QA role as per NC procedure requires (for instance, Originator, Owner, Quality Reviewer, Approver, etc.) as needed.Monitor the process KPIs (PPMs, NCs, etc.) and present any trending to the NCRB and take actions if needed.Make sure the actions are being supported or referenced to the quality system.Promote ideas for continuous improvement of Quality with the end achieve the fulfillment across of the systems simplicity.Support in several areas where his/her experience and technical knowledge about the problem can be useful (production, microbiology, systems, etc.).Perform internal process audits, when required.Keep communication with other departments MX / DK in relation to any quality problem