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- Dr. Ralph Engbrodt
Dr. Ralph Engbrodt
Dr. Ralph Engbrodt is Director Quality Management and Regulatory Affairs of Hemoteq AG, which is part of Freudenberg Medical, a leading global manufacturer of components for medical devices, complex catheter systems for minimally-invasive surgery and total solutions for the biotech, healthcare and pharmaceutical industries.
He studied chemistry at RWTH Aachen in the 90’s and joined the Alfred-Wegener-Institute for his Diploma Thesis on the Analysis of Dissolved Carbohydrates in Polar Marine Environment. This work was followed by a four-year research period resulting in a Ph.D. thesis on the Biogeochemistry of Dissolved Carbohydrates in the Arctic and a three year post doctorate on Dissolved Organic Matter. During his time at the AWI he participated on several research campaigns with RV Polarstern, sampling the various water masses in the Arctic and Antarctic Oceans.
Saying Goodbye to academic research, he moved to the Medical Device Industry in 2006. He joined the Regulatory Affairs Department of Hemoteq AG in 2007, accompanying the regulatory approval of Medical Devices in Europe and international Markets.
He became Head of the Quality Department and Management Representative for the ISO 13485 certification.
As the Management Representative, he is appointed by top management and has responsibility and authority including reporting to top management on the effectiveness of the quality management system and any need for improvements. He is ensuring the awareness of regulatory requirements and quality management system requirements throughout the company.
Since 2015, he is heading both the Quality and Regulatory Affairs teams at Hemoteq.
He studied chemistry at RWTH Aachen in the 90’s and joined the Alfred-Wegener-Institute for his Diploma Thesis on the Analysis of Dissolved Carbohydrates in Polar Marine Environment. This work was followed by a four-year research period resulting in a Ph.D. thesis on the Biogeochemistry of Dissolved Carbohydrates in the Arctic and a three year post doctorate on Dissolved Organic Matter. During his time at the AWI he participated on several research campaigns with RV Polarstern, sampling the various water masses in the Arctic and Antarctic Oceans.
Saying Goodbye to academic research, he moved to the Medical Device Industry in 2006. He joined the Regulatory Affairs Department of Hemoteq AG in 2007, accompanying the regulatory approval of Medical Devices in Europe and international Markets.
He became Head of the Quality Department and Management Representative for the ISO 13485 certification.
As the Management Representative, he is appointed by top management and has responsibility and authority including reporting to top management on the effectiveness of the quality management system and any need for improvements. He is ensuring the awareness of regulatory requirements and quality management system requirements throughout the company.
Since 2015, he is heading both the Quality and Regulatory Affairs teams at Hemoteq.
