Quality Manager BioEngineering (m/f/d)

Quality Manager BioEngineering (m/f/d)

Direct message the job poster from Viscofan

Viscofan 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 Responsibilities

• Maintain and improve the QMS (ISO 13485 & ISO 9001)
• Lead regulatory affairs and monitor standards and changes
• Act as Person Responsible for Regulatory Compliance (PRRC)
• Manage internal and external audits
• Investigate and resolve deviations (CAPAs, change controls)
• Review and approve development documentation (risk analyses, validations)
• Oversee measuring equipment and documentation systems
• Collaborate on process optimization and cross‑functional projects

Qualifications and Key Competencies

• Master’s/Diploma in Biology, Chemistry, Biochemistry or related field
• Proven experience in ISO 13485 environments (GMP is a plus)
• Strong background in regulatory affairs and CE certification
• Experience with biomaterials, hydrogels, or animal‑origin medical devices
• Fluent in German and English (Spanish is a plus)
• Independent, detail‑oriented, and highly organized
• Leadership potential and strong team orientation
• Contribute to impactful biomedical innovations with global reach
• Be part of a committed, international team focused on excellence
• Grow your career in a stable, forward‑thinking company
• Enjoy a collaborative, down‑to‑earth work environment with clear purpose

At Viscofan, we believe in building a diverse, inclusive, and empowered team. We welcome professionals who bring vision, execution, and leadership to the table.

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