Analyst Supplier Quality

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

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

Requirements

B.S., M.S. or equivalent combination of certifications in life sciences and/or engineering or physical sciences; 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; Knowledge of GMP requirements; Knowledge of regional regulations applicable to Medical Products; 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; 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

Nice to have

A degree in engineering, quality management or a comparable field; Continuous Improvement / Lean / Six Sigma; Knowledge in dialysis machines and components or disposables; Deep technical knowledge for manufacturing processes (e.g. injection molding, electronics, chemicals); ISO 9001 and 13485 standards; QMSR/21CFR820; English & German languages; Basic knowledge of data analysis and reporting tools