PURPOSE AND SCOPE:
The System Owner will report into Quality Management and Regulatory Systems Head (QMRS) and will be responsible for overseeing the implementation and maintenance of Quality Management System (QMS) software solutions, including Regulatory Information Management (RIMs) and Regulatory Intelligence (RI) systems. The System Owner will also be responsible for ensuring that these software solutions are compliant with regulatory requirements and meet the needs of our Quality and Compliance teams. They will be an experienced in managing external vendors, software lifecycle management, infrastructure and interface management and experience with server/cloud management would be beneficial.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
EDUCATION:
EXPERIENCE AND REQUIRED SKILLS:
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Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws
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We care about sharing information and experiences as this helps us learn from our mistakes and each other. We tackle challenges together by reaching out to colleagues both near and far. We communicate openly.
We challenge the status quo and show interest in what happens around us. We ask questions to clearly understand what needs to be done and take ownership of the results.
We live up to our own expectations, show respect and lead by example. We act with integrity and in line with our standards every day.
We make things better today than they were yesterday. We pitch ideas on how to improve and innovate.
Empowering people. Advancing care. Inspiring with our purpose and values.
Everything we do here is about making people’s lives better, simpler and longer. Our teams work cross-functionally to reproduce the complex function of kidneys with treatments that meet high quality standards, improve clinical outcomes, and are sustainable and compliant. Internally, we promote diversity and inclusion as key elements of a positive, supportive work environment. Our values support our mission to develop high quality products and services, to have a positive impact on the health and wellbeing of patients, and to lead Fresenius Medical Care towards a successful, sustainable future.