Senior Quality Assurance

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.Demonstrate quality assertiveness and be able to represent quality function in various roles such asproduct support and lifecycle management.Assist in decision making for process improvement efforts and participate in continual processimprovements.Experience in assessing and developing procedures to meet Digital Health regulatory requirements and guidance.Responsible for Quality Assurance of the Product Development and Lifecycle Management process.Provide quality role in assisting with generating design plans, reviewing design inputs, outputs,verification, validation and design transfer strategies for sustenance projects.Support risk management activities for NPD and sustaining engineering products, supporting post market activities such as complaint investigation, complaint trending, CAPA and FA processes.Supporting supplier quality management activities including collaborating with supplier managementteams and conducting supplier audits.Support as a key quality representative in compliance audits and FDA/ministry of health (MOH) inquiries, FDA inspections and ISO/Notified body audits.Collaborate with teams to provide guidance for meeting Vantive Requirements and External QualityStandards as appropriate, including regulatory affairs to meet regulatory requirements.Experience in working with requirements for Test Method Validation, Calibration and Qualification of Test & Measurement equipment in labs used for Verification and Validation and Computer System Validations.BS engineering (Mechanical, Electrical and Electronics) and 6+ years in related Quality or Engineering field in the medical products industry.Strong interpersonal/communication/influencing/negotiation skills.Strong analytical and problem-solving skills.Working knowledge of FDA Regulations and Design Controls requirements for non-active devices and active devices.Experience in the application of design controls and compliance requirements in accordance with 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, EU MDD / EU MDR, Agile SDLC.

Reasonable Accommodation

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