Quality Assurance Engineer for Medical Devices
3 settimane fa
Visionary Quality Assurance for Baxter
Baxter is revolutionizing kidney care and other vital organ support. As a Quality Assurance Engineer for Medical Devices, you will be part of a community of people who are focused, courageous, and driven to improve patients' lives worldwide.
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 and support other Company entities for Audits (internal and external) preparation.
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.
- Critical thinking, problem-solving, collaboration, communications, and negotiation skills are required.
- Proficient knowledge of English.
About Baxter
Baxter is a leading global medical technology company that develops, manufactures, and markets innovative products and solutions that help patients and healthcare providers manage a wide range of medical conditions.
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