长沙招聘

Responsible for works related to Medical Device Adverse Events Monitoring and Re-evaluation, including:  

Maintain and further improve the adverse events and re-evaluation system in China in line with the requirements of the Baxter headquarters and Chinese regulations;

Collect and timely report adverse events to the monitoring authorities, and assist oversea plants for investigation, analysis, evaluation, etc.;

Coordinate with oversea plants to complete key monitoring, periodic risk assessment and re-evaluation on medical devices distributed in China.

Responsible for Imported Medical Device Release

Check CoA, relabeling records and other product related files, release or hold products in JDE system.

QSR for Computer System Validation

Lead quality role in computer system validation , including APP systems.

Qualifications. 
(1)    Strong understanding of and experience in quality management systems;
(2)    Good knowledge on effective quality documentation systems;
(3)    Full competency in local language and a working knowledge of English;

百特国际有限公司提供肾科与医院关键产品的广泛组合，包括居家透析、急重症透析和中心透析产品；无菌静脉输液；输注系统与设备；肠外营养；生物外科产品与麻醉；以及药房自动化、软件和服务。公司凭借全球布局，以及其产品与服务的必需性，在提升新兴与发达国家市场医疗可及性方面发挥至关重要的作用。百特在全球的五万名员工，秉承公司在医疗创新领域的深厚积淀，持续推动未来的医疗创新，更好地满足患者的医疗需求。

Baxter International Inc. provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s 50,000 employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.