Supplier Quality Expert Concentrates (m/f/d)

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.

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