PURPOSE AND SCOPE:

Analysis, monitoring and reporting of the Supplier Quality Management activities & resources for the region EMEA and US.  

PRINCIPAL DUTIES AND RESPONSIBILITIES:  

• Analysis, monitoring and reporting of quality-related key performance indicators (KPIs) in supplier management 
• Analysis and interpretation of KPI  
• Preparation and presentation of monthly quality reports for internal and external stakeholders. 
• Creation of ad hoc reports in supplier management. 
• Support and preparation for the Monthly Management Review (MMR) by providing relevant data and analyses 
• Maintenance and updating of quality data in systems such as Trackwise (supplier data, keeping certificates up to date, material data maintenance, etc.) 
• Identification of trends, deviations and potential for improvement within supplier performance. 
• Close collaboration with Purchasing, Quality Assurance and suppliers to ensure compliance with FME quality standards 
• Support during audits, reviews and continuous improvement reporting processes. 
• 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.

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:

• B.S., M.S. or equivalent combination of certifications in life sciences and/or engineering or physical sciences. 

• A degree in engineering, quality management or a comparable field preferred. 

EXPERIENCE AND REQUIRED SKILLS:        

• More than 6 Years of related experience in quality management, ideally in supplier quality or supplier management
• Experience in analysing, evaluating and reporting on key performance indicators (KPIs) 
• Practical experience in applying quality methodologies (e.g. 8D, root cause analysis, FMEA) 
• Proficiency in using data analysis tools (e.g. Excel, SAP, BI tools) to create reports and dashboards 
• Experience in preparing and presenting management reports (e.g. Monthly Management Review – MMR) 
• Knowledge of quality management systems and tools (e.g. Trackwise or comparable systems) 
• Experience in identifying and implementing improvement measures (Continuous Improvement / Lean / Six Sigma would be an advantage) 
• Preferable knowledge in Dialysis machines and components or disposables. Deep technical knowledge for manufacturing processes e.g. injection molding, electronics, chemicals etc. 
• Analytical skills and a structured, solution-oriented approach to work 
• Strong communication skills and the ability to assert oneself 
• A high degree of personal responsibility and organisational skills 
• Ability to work in a team and intercultural competence 
• Knowledge of GMP requirements,  
• ISO 9001 and 13485 standards, QMSR/21CFR820 preferable 
• Regional regulations, applicable to Medical Products (Device & Drug preferred)  
• English & German Languages preferred. 
• Confident use in SAP (particularly in quality management and master data maintenance) 
• Experience with Trackwise or similar electronic systems 
• Good knowledge of Microsoft applications in general and Microsoft Excel in particular (e.g. reporting, KPI tracking) 
• Basic knowledge of data analysis and reporting tools would be an advantage