Position Summary: This is a Quality Engineering position to ensure ongoing compliance with ISO 13485 and FDA regulations, involving documentation, audits, and corrective actions. Key Highlights: 1. Ensure compliance with ISO 13485 and FDA regulations. 2. Develop and implement quality system documentation. 3. Participate in audits and management of nonconformities (NCRs) and CAPAs. 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. **Key Responsibilities:** This is a Quality Engineering position with quality assurance activities to promote ongoing compliance with ISO 13485 and all FDA regulations, with particular emphasis on 21 CFR Part 820.1, 5, 20, 100, 186, 198, and 250. **Essential Duties and Responsibilities:** * Develop, interpret, and implement quality system documentation. Develop, revise, and maintain Standard Operating Procedures (SOPs) for the assigned area. * May participate in defining departmental quality goals and objectives, and in developing the department budget. * Ensure achievement of quality objectives and effectiveness of corrective actions. * Participate as an audit team member and lead auditor in internal audit processes as required. * Conduct or support investigations, documentation, review, and approval of nonconformities (NCRs) and corrective and preventive actions (CAPAs). * Interact frequently with supervisory and managerial staff, as well as key personnel, providing clear and accurate information that may impact product manufacturing or the quality system. * Support additional quality system-related activities as required by the supervisor, complying with previously established training requirements for such activities. * May be responsible for reporting quality system performance to management. Facilitate and may coordinate the Management Review Meeting, including summary reports and results of audits (internal or external), corrective and preventive actions, areas for continuous improvement, etc. * Support quality system compliance through participation in quality programs and initiatives, in accordance with established procedures, industry standards, and medical device regulations. * Generate metrics for monitoring the quality management system. * Participate in employee training across the company for execution of activities that help maintain, develop, and improve the quality system. May conduct performance evaluations of employees from other departments on practical knowledge of quality system processes. * Coordinate planning and execution activities related to regulatory compliance assurance within quality management systems for processes such as CAPA/NCR, management review, change control management, corporate holds, field actions, and risk management, per established procedures. **Knowledge/Skills/Abilities:** * Intermediate/basic computer skills (Office applications: Word, Excel, PowerPoint, Project, etc.), application software: ERP (Enterprise Resource Planning) systems, and documentation/corrective action software. * Ability to use English at an intermediate level (technical reading and conversation). * Knowledge of ISO 13485 and 21 CFR Part 820. * Technical knowledge in problem-solving, CAPA, DMAIC, etc. * Familiarity with MDSAP (Medical Device Single Audit Program) is desirable. **Education:** Bachelor’s degree in Engineering (Chemical Engineering, Pharmaceutical-Biological Chemistry, Chemical Engineering, Industrial Engineering, or similar disciplines). **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.