Quality Assurance Professional (m/f/d)

Our stated goal is to provide medical professionals with the best possible solutions so that they can find the right answer to every challenge. Fresenius Kabi is a healthcare pioneer for the coming decade. We embrace diversity and value different personalities and attitudes. #karrieremitsinn at Fresenius. Fresenius employs more than 175,000 people worldwide who are committed to ensuring that more and more people gain access to ever-better medicine. We work in international teams to improve the lives of sick people. Regardless of which area of the Group they work in, our employees convey the meaning of our shared pursuit and action: for themselves, for the patients, and for Fresenius. Our work saves lives and makes extraordinary healthcare a reality. Fresenius Kabi is a globally active healthcare company that offers medicines and medical devices for infusion, transfusion, and clinical nutrition. Our products and services are used in the therapy and care of critically and chronically ill patients.

Full-time – Mobile working partially possible – Limited to 2.5 years

In this role, you are responsible for ensuring quality oversight across MedTech sites by promoting consistent QMS implementation, regulatory gap assessments, global quality training, independent quality reviews, and continuous improvement initiatives to strengthen inspection readiness, process maturity, and documentation quality.

Main Responsibilities

• Strengthening quality oversight at assigned sites by monitoring QMS process implementation, identifying gaps, and supporting timely improvement measures.
• Planning, conducting, and documenting structured gap assessments against FDA, QMSR, EU MDR, ISO 13485, MDSAP, and other applicable regulatory expectations.
• Coordination and implementation of global quality training initiatives, including regulatory requirements, Design Controls, Event Handling, and other relevant topics.
• Conducting independent reviews as well as supporting investigations, root cause analyses, effectiveness checks, and documentation completeness.
• Reviewing and supporting the improvement of Risk Files and associated documentation, including consistency, completeness, and linkage with QMS and post-market information.
• Creating gap assessments, KPI overviews, training concepts, action plans, maturity overviews, and management presentations to support governance, performance monitoring, and decision-making.
• Collaborating with global process owners and other stakeholders to drive practical, compliant, and globally scalable process improvements.
• Supporting strategic and digital quality initiatives, including Quality by Design, AI use cases, and other continuous improvement programs.

Experience and Qualifications

• Completed degree in Life Sciences, Engineering, Quality Management, Regulatory Affairs, or a related technical field, or equivalent professional experience.
• Several years of experience in Quality Assurance, Quality Management Systems, Regulatory Affairs, or process improvement in a regulated industry, preferably in the medical device sector.
• Sound knowledge of QMS requirements and regulatory expectations for medical devices, e.g., ISO 13485, EU MDR, FDA QMSR, and MDSAP.
• Practical experience with gap assessments, audits or inspection preparation, QMS process implementation, training rollout, and cross-site improvement activities.
• Practical experience with investigations, CAPA, complaint handling, Non-Conformity Management, root cause analysis, or effectiveness checks is an advantage.
• Good understanding of risk management documentation, interfaces to Design Controls, post-market information, and expectations regarding documentation completeness is desirable.
• Very good written and oral communication skills in English; German or other languages are an advantage.

We are looking for talent and new perspectives. At Fresenius, we are convinced that different perspectives, opinions, experiences, cultures, and values help us to make our company even more successful. All applicants are welcome. All personal designations in this job advertisement apply equally to all genders.

Fresenius Kabi Deutschland GmbH fresenius-kabi.de karriere.fresenius.de fresenius.de