Social network you want to login/join with: Vantive: A New Company Built On Our Legacy Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, but 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 mediocrity. We are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support. *Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions. Summary This position offers an opportunity to implement Product Quality activities within New Product Development (NPD), Sustaining Engineering (SPO), and Regulatory Compliance projects for chronic and acute blood set disposables, based on project assignments received from the Product Quality Manager. You will also participate directly in projects aimed at continuous improvement of product quality, handling design NCR/CAPA as a quality approver. What you’ll be doing Be a member of Project Core teams for New Product Development Projects and design Change Controls as a Product Quality representative. Perform Product Quality activities within NPD, Sustaining Engineering (SPO), and Regulatory Compliance projects for blood set disposables, based on assignments from the Product Quality Manager. Review documents for Device History File issuance and maintenance. Ensure compliance with all applicable Baxter procedures, local work instructions, laws, and standards. Consider complaint data and CAPA corrective actions from current products in sustaining engineering activities. Act as a quality approver for design NCR/CAPA for assigned product families. Collaborate with and support other company entities in audit preparations (internal and external). Periodically report to the Product Quality Manager on activity status. What you’ll bring Degree in Biomedical Engineering, Life Sciences (Chemistry, Biology, etc.), or related fields. Previous experience in the Med-Tech industry focusing on medical devices. Knowledge of Quality Systems based on ISO 13485, FDA, CFR, GMP regulations, and MDSAP. Understanding of Design Control and Risk Management principles. Critical thinking, problem-solving, collaboration, communication, and negotiation skills. J-18808-Ljbffr