Senior Quality Assurance R&D Engineer
2 settimane fa
Visionary Approach to Quality Assurance
Baxter is pioneering a new era in kidney care, separating our ~$5B Kidney Care segment into a standalone company, Vantive. As a key member of our team, you will contribute to building a best-in-class care system for patients worldwide.
At Vantive, you will be part of a community of driven individuals who strive to improve patients' lives through innovative medical devices. We are revolutionizing kidney care and vital organ support, and we invite you to join our journey.
Your Key Responsibilities
- Implement Product Quality activities within New Product Development (NPD), Sustaining Engineering (SPO), and Regulatory Compliance projects for chronic and acute blood sets disposables.
- Participate directly in projects for continuous improvement of product quality handling design NCR/CAPA (as quality approver).
- Review documents for Device History File issuing and maintenance.
- Ensure compliance to all applicable Baxter corporate procedures, local work instructions, and applicable laws and standards.
- Collaborate with other Company entities for Audits (internal and external) preparation.
- Periodically report to the Product Quality Manager about the status of activities under their responsibility.
Your Qualifications
- Degree in Engineering in the Biomedical field or Life sciences (Chemistry, biology...).
- Previous experience in the Med-Tech industry with a focus on medical devices.
- Knowledge and experience of Quality System based on ISO 13485, FDA, CFR, GMP regulation, and MDSAP.
- Knowledge of Design Control and Risk Management principles.
- Critical thinking, problem-solving, collaboration, communications, and negotiation skills.
- Proficient knowledge of English.
About Vantive
Vantive is a new company built on our legacy, aiming to provide best-in-class care to patients worldwide. We believe our separation from Baxter will not only strengthen our leadership in the kidney care space but also offer meaningful work to those who join us.
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