Mag. pharm. Dr. Christian Kraule, MBA

Senior Consultant & QM Expert

Dr. Christian Kraule has more than two decades of experience in the medical and pharmaceutical industries and in quality management. After completing his pharmacy and doctoral studies at the University of Vienna, followed by an MBA focused on international management, he took on leadership roles in several companies, including as managing director of medikus and DOC medikus GmbH.

He works as an external lead auditor for TÜV Nord Austria GmbH and EcoControl, auditing companies for compliance with standards such as ISO 9001, ISO 14001, ISO 13485, ISO 11135, ISO 22716, IFS HPC, as well as MDR and MDD. He also lectures and serves as a reviewer at universities, with a focus on public health and health management.

His passion lies in the practical implementation of normative requirements, process validation, and the strategic development of robust QM systems. His solid academic foundation, numerous publications, and long-standing work as a speaker allow him to bridge theory and practice at the highest level.

Contact: christian.kraule@fox-quality.com | +43 660 944 13 28

Sebastian Schügerl, BSc

Quality Manager & Consultant

Sebastian Schügerl is an experienced quality manager with a hands-on focus on norm-compliant audits, the systematic development of QM systems, and the validation of critical processes and machines.

At Fox Quality, he conducts audits in accordance with ISO 13485, ISO 14001, MDR, MDD, and ISO 11135 and supports companies in preparing, executing, and following up on both internal and external audits and inspections.

He guides the structured implementation of quality management systems from the ground up – tailored to the specific requirements of each industry and company size.

Another focus is on linking regulatory requirements with practical implementation, combining technical understanding and regulatory expertise.

He also conveys QM knowledge in an accessible way through interactive trainings and workshops tailored to the participants’ daily work.

Contact: sebastian.schuegerl@fox-quality.com | +43 660 345 72 54

Philip Kalinka

IT Consultant

Philip Kalinka specializes in the digitalization of quality-relevant processes and the technical implementation of regulatory-compliant IT solutions in the healthcare sector.

As an IT consultant at Fox Quality, he brings extensive experience in planning, developing, and validating software solutions specifically tailored to the needs of quality management systems.

He assists companies in building and optimizing ERP systems with a QM focus and ensures proper documentation and validation according to regulatory requirements.

His key focus is on seamlessly integrating digital tools for process optimization – always aiming to increase efficiency, traceability, and long-term compliance.

Contact: philip.kalinka@fox-quality.com | +43 676 775 90 24