Quality Manager BioEngineering (m/f/d)

🚀 About UsViscofan is the world leader in the production and distribution of casings for the meat industry. With operations in more than 110 countries and a team of over 5,500 people, we combine industrial excellence and innovation to lead both the food and biotechnology markets.Join our BioEngineering Business Unit in Weinheim, Germany, where we develop and manufacture cutting-edge medical devices based on collagen technologies. Our team drives innovation across cell biology and biomedical applications, supported by modern cleanroom facilities and a culture of autonomy, collaboration, and continuous improvement.We are now looking for a Quality Manager BioEngineering (m/f/d) to lead quality and regulatory excellence in a fast-paced, high-impact environment.Your Mission Ensure the highest standards of quality and compliance across our biomedical product portfolio, while driving innovation and process optimization. You will play a key role in maintaining our ISO-certified systems, managing regulatory affairs, and supporting product development from a quality perspective.Key ResponsibilitiesMaintain and improve the QMS (ISO 13485 & ISO 9001)Lead regulatory affairs and monitor standards and changesAct as Person Responsible for Regulatory Compliance (PRRC)Manage internal and external auditsInvestigate and resolve deviations (CAPAs, change controls)Review and approve development documentation (risk analyses, validations)Oversee measuring equipment and documentation systemsCollaborate on process optimization and cross-functional projectsQualifications and Key CompetenciesMaster’s/Diploma in Biology, Chemistry, Biochemistry or related fieldProven experience in ISO 13485 environments (GMP is a plus)Strong background in regulatory affairs and CE certificationExperience with biomaterials, hydrogels, or animal-origin medical devicesFluent in German and English (Spanish is a plus)Independent, detail-oriented, and highly organizedLeadership potential and strong team orientation🌍 Why Join Viscofan?Contribute to impactful biomedical innovations with global reachBe part of a committed, international team focused on excellenceGrow your career in a stable, forward-thinking companyEnjoy a collaborative, down-to-earth work environment with clear purposeAt Viscofan, we believe in building a diverse, inclusive, and empowered team. We welcome professionals who bring vision, execution, and leadership to the table.