• 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

2) 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.