Represent quality in cross-functional projects, ensuring compliance with regulatory and internal quality standards.participate in the execution of quality functions in compliance with fda qsr, iso *, and iso *, and other national and international standards.support process verification and validation activities (iq/oq/pq), including documentation and reporting.collaborate in the development and update of manufacturing documentation, including procedures, work instructions, and risk managementanalyze manufacturing issues and non-conformities to identify root causes and drive continuous improvement actions.support supplier quality activities (audits, validations, changes) and participate in internal and external audits.5–10 years of experience in the medical manufacturing industry as a quality engineerknowledge of iso * and iso *.knowledge of statistical techniques.management of excel, databases, and word processing softwareother requirementsexperience in lean manufacturing (kaizen, continuous improvement, standard work, kanban, 5s, smed, vsm, poka-yoke)#j-*-ljbffr