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Quality Assurance Engineer
2 mesi fa
About Vantive: A New Company Built On Our Legacy
Baxter is embarking on a strategic initiative 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 solidify our leadership in the kidney care space, but also offer meaningful work to those who join us.
Our Vision
At Vantive, you will become part of a community of professionals who are focused, courageous, and committed to excellence. Each of us is driven to help improve patients' lives worldwide. We are revolutionizing kidney care and other vital organ support.
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, based on project assignments received by the Product Quality Manager.
- Participate directly in projects for continuous improvement of product quality handling design NCR/CAPA (as quality approver).
- Review documents for Device History File issuance and maintenance.
- Ensure compliance to all applicable Baxter corporate procedures, as well as all local work instructions and applicable laws and standards.
- Ensure that complaint data and CAPA corrective actions from current products are considered in sustaining engineering activities.
- Quality approver of design NCR/CAPA for the product families assigned.
- Collaborate and support other Company entities for Audits (internal and external) preparation.
- Periodically report to Product Quality Manager about the status of activities under his/her responsibility.
Requirements
- Degree in Engineering in the Biomedical field or Life sciences (Chemistry, biology...)
- Previous experience in the Med-Tech industry with 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 are required
- Proficient knowledge of English
