DesignProjectQualityEngineer

medmix es líder mundial en dispositivos de administración de alta precisión, con posiciones de liderazgo en los mercados finales de la sanidad, consumo y la industria. Nuestros clientes se benefician de nuestra orientación a la innovación y al avance tecnológico, que se ha traducido en más de 900 patentes activas. medmix tiene su sede central en Baar, Suiza y 14 centros de producción en todo el mundo, que, junto con nuestro equipo altamente motivado y experimentado de casi 2.700 empleados, estamos al servicio de nuestros clientes con una calidad, proximidad y agilidad sin concesiones. Nuestras acciones cotizan en el SIX Swiss Exchange (SIX: MEDX). [www.medmix.swiss](https://www.medmix.swiss) Job purpose The Design Project QE facilitates site regulatory compliance for medmix Healthcare US Inc for incoming project design transfers. This individual ensures product reliability and regulatory compliance throughout the design and development lifecycle, bridging the gap between engineering design, manufacturing, and quality standards. They manage the design transfer to the manufacturing site, risk assessment (ISO 14971), and verification/validation (V&V), crucial in regulated industries like medical devices, pharmaceutical, or manufacturing and will assist with the development of processes and procedures that the DEA and FDA require for cGMP compliance when processing combination drug product. This individual will help to ensure that all required DEA records are retained in a manner that they are easily retrievable and are complete in order to show inventory control and accountability. They will also assist with completing year-end inventories, inventory reconciliation, discrepancy investigations, and support or represent the business in matters of FDA and DEA investigations and audits. This role is critical in maintaining adherence to regulations, processing Standard Operating Procedures (SOPs), and regulatory compliance for controlled substances. The individual must demo