Senior Expert Quality Management International (m/f/d)

Senior Expert Quality Management International (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.

Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth.

Overall aim of the position:

As Senior Expert Quality Management International, you will play a key role in supporting and strengthening Fresenius Medical Cares international Quality Management System (QMS). You will support the Management System Representative, Head of QMS International, in the development, maintenance and implementation of the international QMS for Medical Devices, pharmaceutical quality requirements and GxP-relevant systems.

The purpose of this position is to ensure regulatory compliance, inspection readiness and effective implementation of the Quality Management System across relevant international business areas. In this role, you will act as an important interface between Corporate Headquarters, global functions, international business areas and QMS related functions.

Your tasks:

Supporting the implementation, maintenance and continuous improvement of the international Quality Management System

Providing implementation support to relevant business areas and overseeing implementation status

Ensuring regulatory compliance and inspection readiness of the Medical Device QMS, pharmaceutical quality systems and GxP-relevant processes

Supporting management oversight activities related to the quality system

Preparing, supporting and following up on regulatory authority inspections, certification audits and TÜV audits

Ensuring required certifications, licenses and authorizations, such as MDSAP, ISO 13485 and GxP, as applicable to the respective business area

Coordinating strategic initiatives, ensuring execution and implementation

Providing reports to management about key QMS indicators and other related Q metrics

Your profile:

At least 10 years of experience in Quality Management Systems or Regulatory Affairs within the healthcare industry, including at least 5 years in the medical device industry or relevant experience in pharma or GxP environments such as GMP or GDP

Strong knowledge of Medical Device Quality Management, GxP requirements, applicable regulatory requirements and relevant certification standards, including ISO 13485 and MDSAP

Proven experience in implementing, maintaining or improving QMS or other management systems in a responsible function

Experience in preparing, hosting, leading and following up on regulatory authority inspections, TÜV audits or certification audits

Ability to read, understand and interpret regulations and translate them into practical business processes

Good knowledge of MS Office applications as well as practical experience with ERP systems and workflow solutions

Very good English skills; additional languages are a plus

Experience in leading diverse teams in multi-site, international environment