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. **Your role at Vantive:** You will be responsible for managing quality in processes, systems, and plant products according to standards established by applicable current regulations and standards (ISO 9001, ISO 13485, FEUM, and NOM 241), as well as maintaining and complying with quality systems in accordance with established indicators. **What you will do:** * Evaluate and make decisions to resolve problems. * Integrate and collaborate with different work areas. * Ensure compliance with Vantive's corporate policies. * Verify compliance with the quality management system according to current standards NOM-241, ISO 9001, and ISO 13485. * Comply with procedures related to Documentation and GMP. * Manage the handling and analysis of complaints to ensure that for each received complaint, appropriate investigations are conducted, necessary corrective and preventive actions are implemented, and a system is established to measure the effectiveness of the actions taken. * Develop and implement an audit system. * Contribute to compliance with applicable current regulations by immediately notifying the Regulatory Officer of any detected health-related irregularity. * Manage the nonconformities process to ensure that any deviation from established procedures is investigated, reviewed, and resolved. * Manage the product recall process from the market and follow up on its execution. * Ensure compliance with safety procedures for activities and personnel under your responsibility, in accordance with international standards ISO 14001, 45001, and Mexican Official Standards on safety. * Manage and develop a comprehensive process to evaluate, identify, monitor, and reduce risks. * Manage the change control process impacting the Quality Management System. * Ensure regulatory compliance based on current legal provisions. * Identify compliance and legal risks for Vantive within the country/cluster. * Promote the implementation of the ethics and compliance program and prevent, detect, and correct violations of laws, Vantive policies, and the code of conduct. **What you will bring:** Bachelor's degree in Chemistry and Pharmaceutical Biology, Pharmaceutical and Industrial Chemistry, Chemical Engineering, Chemistry, or related chemical and/or pharmaceutical fields. Solid knowledge in Good Documentation Practices, Good Manufacturing Practices, Quality Management Systems, and the Mexican Official Standard NOM-241, ISO 9001, ISO 13485 (current version). 2 years of experience in quality management systems. **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.