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Skills: Data Analytics, Statistical Analysis, Quality Management, CAPA, Predictive Analytics
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Full-time
Posted 5d ago
Apply by Nov 30
~40 hrs/week
Responsibilities
The Senior Specialist will establish statistical analysis tools and support quality initiatives to improve product processes and QMS compliance. They will also generate data reports, perform risk assessments, and utilize predictive analytics to identify quality issues.
Requirements
The role requires expertise in data analytics, quality management systems, and regulatory compliance within a manufacturing or medical device context. Candidates should be proficient in data reporting, process optimization, and the application of statistical methods to support global quality performance.
Full job description
Major Task
Establishmentof statistical analysis tools and methods
SupportMajor Quality Initiatives to continuously improve the processes as well as the product quality of relevant products (especially with focus on product related processes of the QMS)
Supportreview and adjustment(optimization of fit for use and reduction of non-added value) of quality processes such as CAPA, Compliant Handling, Training, Internal/External Audit, GPDP, Change Management, Risk Management, Management Reviewetc.
Support the continuous harmonization of the application of tools (likee.g.GPDM, QTRAK, QDATA) linked to the processes across the Vertical in Center and the related units like plants
Supportglobal plants to implement new or changing regulations and sustainability requirements
Support theestablishmentand maintenance of framework for Business Performance assessment that are related toe.g.product quality, customercomplaints, cost of poorqualityetc.
Supportestablishingquality datametricsfor various internal customers, reviews,reportsand forums.
Generate reports and data extracts for Quality Management,advancedanalyticsand research from both external and internal data sources.
Support theassessment ofpotential product risks (from data reporting, prediction of performance and/or market observation andidentifiedquality problems)byproviding initial evaluations ofe.g.data reports
Key contributiononcreation and maintenance of quality reporting for leadership
Pre-assess and supports investigatingcomplex data related issues and synthesizes quantitative and qualitative information using past, current, and future trending information
Initiateand support theanalyses and investigationof quality issues
Assistwith variousprojects asassigned by a direct supervisor.
Support CAPA processing bye.g.data analysisand reports
2) Secondary tasks:
Supportexternal and internal auditrequestswithin Vertical organizationby providing data
Utilizationof predictive analyticsand AI tosupport the identification and reporting of potential and actual quality relatedissues.
Supportthe global quality performance tracking and reporting process and tools supporting In Centre global medical devices product conformity.
Fresenius Medical Care is the world’s leading provider of products and services for individuals with renal diseases. We aim to create a future worth living for chronically and critically ill patients – worldwide and every day.
Thanks to our decades of experience in dialysis, our innovative research and our value-based care approach, we can help them to enjoy the very best quality of life.
Our portfolio encompasses a comprehensive range of high-quality health care products and services as well as various dialysis treatment options for both in-center and home dialysis that are individually tailored to our patients’ needs.
Offices: Else-Kröner-Strasse 1, Bad Homburg, Frankfurt 61352, DE
dialysishemodialysishome dialysiskidney diseaserenal carekidneynephrologyhealthcareand medtechHealth Care
Fresenius Medical Care is the world’s leading provider of products and services for individuals with renal diseases. We aim to create a future worth living for chronically and critically ill patients – worldwide and every day.
Thanks to our decades of experience in dialysis, our innovative research and our value-based care approach, we can help them to enjoy the very best quality of life.
Our portfolio encompasses a comprehensive range of high-quality health care products and services as well as various dialysis treatment options for both in-center and home dialysis that are individually tailored to our patients’ needs.
Offices: Else-Kröner-Strasse 1, Bad Homburg, Frankfurt 61352, DE
dialysishemodialysishome dialysiskidney diseaserenal carekidneynephrologyhealthcareand medtechHealth Care