PURPOSE AND SCOPE:

The role is critical to support accessing and communicating all performance aspects that are related to Verticals and SQR including gathering and analyzing relevant quality data and KPIs to support evidence-based decision making.

Support SQR vertical data analytics activities that are linked to product quality strategy, registration strategy, patient safety and compliance and the technical documentation about the products.

Takes necessary actions to ensure the efficient and timely preparation of routine reports, and data extracts to support various departments within the organization. Responsible for creating actionable evidence-based analytics to support the company's partnerships with accountable Care Enablement organizations and other strategic arrangements. Other clinical analytics and project based analytical efforts including data science efforts may be assigned.

The role is critical to support accessing and communicating performance aspects that are related to the SQR Vertical and others.

PRINCIPAL DUTIES AND RESPONSIBILITIES:  

• Establishment of statistical analysis tools and methods
• 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
• Assist with various projects as assigned by a direct supervisor.
• Support CAPA processing by e.g. data analysis and reports.
• 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 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.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands and work environment characteristics described here represent those employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

EDUCATION:

Degree level holder - Technical/Scientific Discipline

EXPERIENCE AND REQUIRED SKILLS:        

• More than 3 to 5 Years of related experience
• Knowledge of relevant standards and regulations – i.e. 21 CFR 820, ISO13485, ISO14971 etc.
• Preferably work experience in a multinational company Good communication skills
• Good knowledge of quality management, or the subject field of approving complex systems
• Advanced knowledge and experience in data analytics and/or statistical methods
• Basic knowledge of applicable quality standards (e.g., ISO13485, ISO14971, EU Guidelines for GMP, 21 CFR §820, MDSAP, etc.)
• Basic knowledge of medical device regulations (MDD 93/42/EEC, MDR 2017/745, etc.)
• Basic knowledge of internal and external processes and structures and of the Quality Management System requirements
• Statistical Techniques
• Required: Office (Excel/Word/Power Point),
• Required: Experience in data visualization and relevant software (e.g. Tableau, PowerBI, etc)
• Additional: Workflow systems like Trackwise, IQVIA, PDM systems like PTC Windchill, Minitab
• Additional: ERP systems.
• Preferred: Experience with AI models, automations e.g. via Python, SQL

• Ability to maintain professional relationship to, and communication with colleagues and to internal customers, integrating attitude.
• High engagement on achieving the targets and on the objectives of the position, proactive and solution-oriented approach towards problems and priority setting.
• Ability to effectively work with people across various geographies and cultures.
• Ability to work through assignments independently.
• Highly developed and proven analytical and statistical skills.
• Pro-active, change & solution oriented.
• Continuous optimization approach, integrating attitude, drive for results.