Fresenius Medical Care
Supplier Quality Expert Concentrates (m/f/d)
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At Fresenius Medical Care
We are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision—“Creating a future worth living. For patients. Worldwide. Every day.”—we work with purpose and compassion, supported by a global team of over 110,000 employees.
Our values guide how we work:
- We Care for our patients, each other, and our communities
- We Connect across teams and borders to deliver excellence together
- We Commit to doing things the right way— growing with purpose and leading kidney care with integrity and innovation
Your assignment:
Responsibility for Supplier Quality Management within the Concentrate Products
- Implements Supplier Quality Assurance systems within the assigned region and plants, aligning them to FME global policies and standard operating procedures (SOP).
- Responsible for SOP deployment and training in the assigned plants.
- Qualification, selection and continuous development of suppliers
- Planning and conducting supplier audits (on-site & remote) in accordance with, ICH Q7, GMP, IPEC, ISO 9001, ISO 13485 and regulatory requirements
- Ensuring material and product quality throughout the supply chain
- Analysis and handling of:
- Deviations
- Complaints
- CAPA processes (Corrective and Preventive Actions)
- Assessment and approval of supplier changes (Change Control)
- Lead continuous improvement initiatives together with suppliers.
- Escalate critical supplier quality issues to management and cross-functional teams.
- Support for transfer projects between sites/suppliers.
- Supports suppliers in process validation, risk management and change management activities
- Ensure data integrity and documentation in accordance with ALCOA+ principles
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Your profile:
- Bachelor of Science degree (B. S.) in Engineering, Chemistry, quality management or a comparable field
- Professional 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
- Knowledge of quality management systems and tools (e.g. Trackwise or comparable systems)
- Experience with concentrates, sterile manufacturing, pharmaceutical raw materials, or critical components is desirable
- Training Experience is desirable
- Knowledge of ICH Q7, IPEC and GMP requirements, ISO 9001 and 13485 standards, QMSR/21CFR820 preferable
- Regional regulations, applicable to Medical and Medicinal Products (Device & Drug preferred)
- Experience with broad base of chemicals, excipients and APIs
- GMP in the manufacture of sterile products
- Project Management
- Excellent command of German and English; knowledge of Spanish and French would be an advantage
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Our Offer for you:
There is a lot you can discover at Fresenius Medical Care, regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey.
- Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world
- Individual opportunities for self-determined career planning and professional development
- A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
- A large number of committed people with a wide range of skills, talents and experience
- The benefits of a successful global corporation with the collegial culture of a medium-sized company
We are committed to diversity and equal opportunities and welcome applications from people with disabilities.
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