Senior Quality Management Professional (m/f/d)

DE01 DEU Fresenius Medical Care D. GmbH; Bad Homburg vor der Höhe; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Career development

Diversity & inclusion

Global corporation culture

Job summary

Fresenius Medical Care AG is seeking a Senior Quality Management Professional to strengthen the international Quality Management System across global business areas. You will collaborate with Corporate HQ, global functions, and QMS teams to ensure compliance and audit readiness.

The role requires deep experience in healthcare quality systems, strong regulatory knowledge, and proven project leadership in complex, multinational environments. Fluent English is essential; German is a plus.

Qualifications

• 10+ years in Quality Management Systems in healthcare.
• 5+ years in medical device or pharma/GxP environments.
• Strong knowledge of ISO 13485, MDSAP and GxP requirements.
• Experience preparing for regulatory inspections and audits.
• Ability to translate regulations into practical processes and QMS architecture.
• Experience coordinating cross-functional, multinational projects.

Responsibilities

• Drive and improve the international Quality Management System.
• Provide guidance to business areas and oversee implementation status.
• Ensure regulatory compliance and inspection readiness of QMS.
• Prepare and support regulatory inspections and audits.
• Coordinate strategic QMS initiatives and stakeholder engagement.
• Report QMS indicators to management and support oversight.
• Support internal and external audits and continuous improvement.

Skills

Quality Management Systems

GxP regulations

ISO 13485

MDSAP

Regulatory inspections

ERP systems

MS Office

Cross-functional leadership

English proficiency

Education

Experience in healthcare quality management

Tools

ERP systems

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. 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 Quality Management Professional, you will play a key role in supporting and strengthening Fresenius Medical Care’s 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

• Driving and supporting the implementation, maintenance and continuous improvement of the international Quality Management System
• Providing guidance and 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
• 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 suitable planning, execution and implementation
• Actively managing and engaging key stakeholders across Corporate Headquarters, global functions and international business areas to ensure effective collaboration and consistent QMS implementation.
• Supporting management oversight activities related to the quality system
• Providing reports to management about key QMS indicators and other related Q metrics
• Supporting and conducting internal and external audits, as applicable, and contributing to the continuous improvement of the international QMS.

Your profile

• At least 10 years of experience in Quality Management Systems 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 of medical device quality management systems, pharmaceutical quality requirements, GxP regulations and applicable international regulatory frameworks and 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 processes and the management system architecture
• Proven experience in leading projects and coordinating cross-functional teams in complex, international and multi-site environments
• Experience working in large, multinational organizations with complex organizational structures and international stakeholder environments
• Strong prioritization skills, accountability and the ability to manage ambiguity in changing business environments
• Willingness to respond quickly in critical situations, such as quality issues or unannounced audits, and to work globally across different time zones
• Good knowledge of MS Office applications as well as practical experience with ERP systems and workflow solutions
• Very good English skills; german skills are a plus

Your 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 support diversity and equal opportunity and welcome applications from people with disabilities!

Creating a future worth living. For patients. Worldwide. Every day.

Fresenius Medical Care is the world's leading provider of products and services for individuals with kidney disease of which approximately 4.5 million patients worldwide regularly undergo dialysis treatment.

United by a shared purpose of creating a future worth living for chronically and critically ill people, we care for around 292,000 dialysis patients around the globe.

In addition, we operate around 35 global production sites to provide products such as dialysis machines, dialyzers, and related disposables.

We aim to continuously improve our patients’ quality of life by offering them high-quality products as well as innovative technologies and treatment concepts.