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Quality Assurance and Research Development Specialist

2 mesi fa

Medolla, Emilia-Romagna, Italia Baxter A tempo pieno

Vision for the Future of Kidney Care

Baxter is embarking on a journey to separate its ~$5B Kidney Care segment into a standalone company, Vantive. This new company will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to those we serve.

As a member of the Vantive team, you will become part of a community of focused, courageous individuals who are driven to improve patients' lives worldwide. Our goal is to revolutionize kidney care and other vital organ support.

Key Responsibilities

  1. Implement Product Quality activities within New Product Development (NPD), Sustaining Engineering (SPO) and Regulatory Compliance projects for chronic and acute blood sets disposables.
  2. Participate in projects for continuous improvement of product quality handling design NCR/CAPA as a quality approver.
  3. Review documents for Device History File issuing and maintenance.
  4. Ensure compliance to all applicable Baxter corporate procedures and local work instructions and applicable laws and standards.
  5. Ensure that complaint data and CAPA corrective actions from current products are considered in sustaining engineering activities.
  6. Quality approver of design NCR/CAPA for the product families assigned.
  7. Collaborate and support other Company entities for Audits (internal and external) preparation.

Requirements

  1. Degree in Engineering in the Biomedical field or Life sciences (Chemistry, biology).
  2. Previous experience in the Med-Tech industry with focus on medical devices.
  3. Knowledge and experience of Quality System based on ISO 13485, FDA, CFR, GMP regulation and MDSAP.
  4. Knowledge of Design Control and Risk Management principles.
  5. Critical thinking, problem-solving, collaboration, communications and negotiation skills are required.
  6. Proficient knowledge of English.

Becoming Part of the Team

By joining Vantive, you will have the opportunity to be part of a community that is dedicated to improving patients' lives worldwide. We are looking for individuals who share our vision and are passionate about making a difference in the field of kidney care and other vital organ support.