Senior Expert Quality Management International (mfd)

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 work with purpose and compassion supported by a global team of over 110000 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 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 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

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

Required Experience:

Senior IC

Employment Type : Full-Time
Experience: years
Vacancy: 1