Establishment of statistical analysis tools and methods
Support Major 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)
Support review 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 Review etc.
Support the continuous harmonization of the application of tools (like e.g. GPDM, QTRAK, QDATA) linked to the processes across the Vertical in Center and the related units like plants
Support global plants to implement new or changing regulations and sustainability requirements
Support the establishment and maintenance of framework for Business Performance assessment that are related to e.g. product quality, customer complaints, cost of poor quality etc.
Support establishing quality data metrics for various internal customers, reviews, reports and forums.
Generate reports and data extracts for Quality Management, advanced analytics and research from both external and internal data sources.
Support the assessment of potential product risks (from data reporting, prediction of performance and/or market observation and identified quality problems) by providing initial evaluations of e.g. data reports
Key contribution on creation and maintenance of quality reporting for leadership
Pre-assess and supports investigating complex data related issues and synthesizes quantitative and qualitative information using past, current, and future trending information
Initiate and support the analyses and investigation of quality issues
Assist with various projects as assigned by a direct supervisor.
Support CAPA processing by e.g. data analysis and reports
Secondary tasks:
Support external and internal audit requests within Vertical organization by providing data
Utilization of predictive analytics and AI to support the identification and reporting of potential and actual quality related issues.
Support the global quality performance tracking and reporting process and tools supporting In Centre global medical devices product conformity.
