Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. * This is a Quality Engineering position with validation activities focused on executing and verifying maintenance of the site's validated status, ensuring equipment operates efficiently and correctly to produce quality products. * Responsible for the development, coordination, and execution of validation and qualification protocols to comply with internal policies and international standards, as well as strengthening continuous improvement in manufacturing processes and critical service production. 1. Monitor compliance with FDA regulatory requirements for countries where the product is exported, international standards (ISO 9001/ISO 13485), and corporate requirements, with special attention to 21CFR 820.22, 30, 65, 70, 75, 90, 100, 130, 184, and 198. 2. Statistical analysis of process variation, process/product control, risk analysis of product families within the plant, implementation of improvement actions resulting from data analysis of internal and external product experience. 3. Ensure compliance with applicable regulations to maintain validation status. 4. Perform qualification and validation process activities. 5. Qualify critical equipment and systems used in manufacturing processes. 6. Comply with the current Validation Master Plan. 7. Review validation protocols and reports. 8. Collect supplementary information related to validation protocols. 9. Develop and maintain updated procedures applicable to qualification and validation processes according to corporate standards and national and international legislation. 10. Comply with GAMP 5, EC Annex 11, 21 CFR Part 11, and international standards focused on computerized system validation and data integrity application. 11. Ensure qualification and operation of controlled areas within applicable environmental specifications. 12. Participate in the decision-making structure regarding regulatory compliance and quality standards across all operations described above. 13. Provide direct support during regulatory inspections. 14. Support compliance with the Quality System by participating in investigations as owner, ensuring that activities related to NCR/CAPA follow-up are executed, completed, and properly documented. 15. In addition, if involved as a quality approver, responsible for ensuring that investigations have had proper root cause analysis and that investigation closures or actions have been correctly executed, meet system requirements, and are appropriately documented. **Reasonable Accommodation** Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link **Recruitment Fraud Notice** Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.