PURPOSE AND SCOPE:
Management of the Supplier Quality Management activities & resources for the region EMEA and US. Management der Aktivitäten und Ressourcen des Qualitätsmanagements für Lieferanten in der Region EMEA und US.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Supplier onboarding
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Qualification and approval of new suppliers in accordance with internal FME processes and quality standards
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Conducting risk analyses and initial assessments of suppliers
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Assessing and ensuring compliance with supplier quality standards
Audit Management
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Planning, organizing and conducting supplier audits (e.g. system and process audits)
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Developing and maintaining the supplier audit program
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Documenting audit findings and evaluating supplier performance
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Following up on audit non-conformities and action plans
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Ensuring the timely and sustainable implementation of corrective actions
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Verifying the effectiveness of implemented measures
Master Data Management
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Maintaining and updating supplier and quality data in the Trackwise and SAP (S/4, ECC 6.0) systems
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Ensuring data quality and consistency
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Supporting the analysis of quality-related key performance indicators
Quality Agreements (QAAs)
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Drafting, coordinating, negotiating and monitoring the validity of quality agreements with suppliers
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Ensuring the contractual implementation of quality requirements
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Providing support in the event of escalations and supplier development measures
PHYSICAL DEMANDS AND WORKING CONDITIONS:
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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:
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B.S., M.S. or equivalent combination of certifications in life sciences and/or engineering or physical sciences.
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A degree in engineering, quality management or a comparable field
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preferred.
EXPERIENCE AND REQUIRED SKILLS:
- More than 7 Years of related experience in supplier quality management, preferably in relation to supplier activities within the medical sector.
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Analytical skills and a structured, solution-oriented approach to work
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Strong communication skills and the ability to assert oneself
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A high degree of personal responsibility and organisational skills
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Ability to work in a team and intercultural competence
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Knowledge of GMP requirements,
- ISO 9001 and 13485 standards, QMSR/21CFR820 preferable
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Regional regulations, applicable to Medical Products (Device & Drug preferred)
- Understanding of Medical Products/Manufacturing processes.
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In-depth knowledge of audit methods (ISO 19001)
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Preferable knowledge in Dialysis machines and components or disposables. Deep technical knowledge for manufacturing processes e.g. injection molding, electronics, chemicals etc.
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English & German Languages preferred.
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Confident use in SAP (particularly in quality management and master data maintenance)
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Experience with Trackwise or similar electronic systems
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Good knowledge of Microsoft applications in general and Microsoft Excel in particular (e.g. reporting, KPI tracking)
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Basic knowledge of data analysis and reporting tools would be an advantage
