Senior Quality Management Professional (m/f/d)

Fresenius Medical Care AG; Bad Homburg vor der Höhe; Sur place; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Career development

Global corporation culture

Diversity and equal opportunity

Résumé du poste

Fresenius Medical Care is 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.

The Senior Quality Management Professional will support and strengthen the international QMS, collaborating with Corporate HQ, global functions, and international business areas to ensure regulatory compliance, inspection readiness, and effective

Qualifications

• Over 10 years in Quality Management Systems in healthcare, with 5+ years in medical devices or GMP/GxP.
• Strong knowledge of medical device QMS, pharma quality requirements and ISO 13485/MDSAP.
• Experience implementing or improving QMS in a multinational setting.
• Experience leading regulatory inspections and audits (e.g., TÜV, certification).
• Ability to translate regulations into practical processes and system architecture.
• Proven cross-functional project leadership in international, multi-site environments.
• Experience in large multinational organizations with complex structures and international stakeholders.
• Strong prioritization, accountability and ability to manage ambiguity.
• Willingness to respond quickly in critical situations and work across time zones.
• Good knowledge of MS Office; experience with ERP and workflow solutions.

Responsabilités

• Drive, implement, maintain and continuously improve the international QMS.
• Provide guidance to business areas and oversee implementation status.
• Ensure regulatory compliance and inspection readiness of QMS, GMP/GxP processes.
• Prepare for regulatory authority inspections and audits (TÜV, certification).
• Ensure certifications and licenses such as MDSAP, ISO 13485, GxP.
• Coordinate strategic initiatives with planning, execution and rollout.
• Engage stakeholders across HQ, global functions and international areas.
• Support management oversight activities related to the quality system.
• Provide management reports on QMS indicators and related metrics.
• Support and conduct internal and external audits and drive continual improvement.

Connaissances

Quality management

Regulatory awareness

GxP knowledge

Project leadership

Stakeholder engagement

MS Office

ERP systems

English proficiency

German is a plus

Outils

MS Office

ERP systems

Workflow solutions

Description du poste

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.

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

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