Quality Manager BioEngineering

vor 1 Woche

Weinheim, Baden-Württemberg, Deutschland Viscofan Vollzeit 60.000 € - 100.000 € pro Jahr


About Us

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


Why Join Viscofan?

  • 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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