This is a permanent, full-time position to work at our Cartago site, located in Zona Franca La Lima. Benefits include medical insurance, association, gym, cafeteria subsidy, free transportation, and more. Our Sterile Release Assistant is a bilingual Quality Assistant responsible for conducting the release of sterile finished goods, ensuring that quality documentation meets requirements prior to release. Major areas of accountability: Carrying out sterile release in E1 (ERP system) after sterilization of the products, following written instructions. Issuing, reviewing, updating, and implementing documents related to sterilization activities. Handling inquiries regarding product status, transactions, and locations in E1 during out-of-the-ordinary events. Ensuring necessary actions are taken in case of out-of-specification events related to sterilization. Performing physical condition checks on product boxes returned from the sterilization supplier, reporting damages, and taking necessary actions. Monitoring the handling of products to be sterilized from a quality assurance perspective before sterilization. Performing post-sterilization tests on sample products, recording data, and storing samples according to procedures. Managing NCRs related to sterilization, ensuring timely closure in accordance with procedures. Communicating out-of-specification events requiring product quarantine. Ensuring documentation of sterilized products is revised and archived per internal procedures. Responsibilities include: Performing job duties in compliance with provided guidelines. Reporting difficulties in understanding or following guidelines to the manager. Highlighting system inefficiencies. Taking responsibility for safety aspects of the position. Having a Technical Degree in Quality or Production. Minimum English proficiency B1 (oral and written). 1-3 years of practical experience in Medical Device Manufacturing in similar roles. Proficiency in MS Office (Word, Excel), Outlook, and database management. Preferred qualifications: Knowledge of sterilization validation. Familiarity with e-beam sterilization. Background in sterile medical device manufacturing. Coloplast Group - Holtedam 1 - Humlebaek - DK 3050 - Denmark #J-18808-Ljbffr