Pioneering 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 benefit patients by preventing infections, protecting at-risk skin, improving outcomes, and reducing care costs. Convatec’s revenues in 2023 exceeded $2 billion. The company is a FTSE 100 Index constituent (LSE:CTEC). To learn more, visit Convatec Group. Key Responsibilities: Manage and execute quality compliance activities according to local regulations. Ensure renewal and maintenance of licenses and authorizations for medical devices and cosmetics in LATAM countries. Participate in audits, ensuring compliance with standards and best practices. Establish and maintain management processes and SOPs in line with local regulations, collaborating across functions. Develop, implement, and maintain QA procedures. Monitor and support the quality system, reviewing procedures and maintaining quality records. Input and update data in global Convatec Systems. Coach QA Analysts and report non-conformities based on warehouse inputs in LATAM. Manage customer complaint processes, coach staff to report complaints within 24 hours into Trackwise, and monitor trends. Coordinate quality concerns with distributors and customers, manage responses, and escalate as needed. Follow up on overdue complaints and ensure closure. Qualify GxP suppliers per global procedures, compile documentation, and support onboarding. Oversee distribution quality activities in LATAM, including quality agreements and certificates. Ensure warehouse activities comply with storage, transportation, traceability, and inspection standards. Support training and documentation efforts. Coordinate stop ship activities, re-inspections, and report results. Represent Supplier Quality in quarterly reviews and escalate issues for improvement. Audit distribution centers and transportation providers, compile reports, and manage CAPAs and SCARs. Investigate transportation-related complaints and execute post-market activities like recalls. Consolidate recall responses and report to Global Quality. Develop and maintain procedures for local labeling, collaborate on artwork updates, and implement labeling changes. Implement CAPA modules across LATAM, track and ensure closure of corrective actions. Conduct internal training on regulations and quality standards, establish training matrices, and maintain curricular in Compliance Wire. Skills & Experience: Bachelor’s degree in Science, Engineering, or Medical Technology. Experience in post-market quality assurance in the medical device industry; regional stakeholder management is a plus. Proficiency in English is mandatory. Knowledge of Quality Management Systems like ISO-13485:2016. Understanding of national and international regulations (e.g., ANVISA, RDCs, ISO). Experience managing field safety actions is desirable. #J-18808-Ljbffr