Analyst Supplier Quality

PURPOSE AND SCOPE:

Analysismonitoringand reportingof the Supplier Quality Management activities & resources for the region EMEAand US.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Analysismonitoringand 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 andupdating ofquality data in systems such asTrackwise(supplier data keeping certificates up to date material data maintenance etc.)
• Identification of trendsdeviationsand potential for improvement within supplier performance.
• Close collaboration with Purchasing QualityAssuranceand suppliers to ensure compliance with FME quality standards
• Support during audits reviews and continuousimprovementreportingprocesses.
• 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:

• equivalent combination of certifications in life sciences and/or engineering or physical sciences.

• A degree in engineeringqualitymanagementor a comparable fieldpreferred.

EXPERIENCE AND REQUIRED SKILLS:

• More than 6 Years of related experience in quality management ideally in supplier quality or supplier management
• Experience inanalysingevaluatingand reporting on key performance indicators (KPIs)
• Practical experience in applying quality methodologies (e.g.8D root cause analysis FMEA)
• Proficiencyin using data analysis tools ( SAP BI tools) to create reports and dashboards
• Experience in preparing and presenting management reports ( Management Review MMR)
• Knowledge of quality management systems and tools ( comparable systems)
• Experience inidentifyingand 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 molding electronicschemicalsetc.
• Analytical skills and a structured solution-oriented approach to work
• Strong communicationskills and the ability to assert oneself
• A high degree of personal responsibility andorganisationalskills
• Ability to work in a team and intercultural competence
• Knowledge of GMP requirements
• ISO9001 and 13485standardsQMSR/21CFR820 preferable
• Regional regulations applicable to Medical Products (Device & Drug preferred)
• English &GermanLanguages preferred.
• Confident usein SAP (particularly in quality management and master data maintenance)
• Experience withTrackwiseor similarelectronic systems
• Good knowledge of Microsoft applications in general and Microsoft Excel in particular ( KPI tracking)
• Basic knowledge of data analysis and reporting tools would be an advantage