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 inno