Supplier Quality Expert Concentrates (m/f/d)

Job description

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 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 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.