Head of Quality & Digital Quality

The Head of Global Management Systems and Digital Quality is responsible for the strategic leadership, development, and continuous improvement of the global Quality Management System (QMS) for Medical Devices, ensuring compliance with international standards and regulations. This role oversees the integration of digital solutions into the QMS ecosystem and ensures their compliance with applicable regulatory frameworks. The role also includes managing a global team of quality professionals and expanding the QMS to support new product portfolios that reach across different industries.

The Head of Global Management Systems and Digital Quality is responsible for the strategic leadership, development, and continuous improvement of the global Quality Management System (QMS) for Medical Devices, ensuring compliance with international standards and regulations. This role oversees the integration of digital solutions into the QMS ecosystem and ensures their compliance with applicable regulatory frameworks. The role also includes managing a global team of quality professionals and expanding the QMS to support new product portfolios that reach across different industries.

Your Role

The Head of Global Management Systems and Digital Quality will involve:

• Provides ZEISS Vision Care Group governance over the Integrated Quality Management System (QMS) to ensure its application across EMEA/LA/AP aligns with implementation intent and regulatory requirements (e.g., ISO 9001, ISO 13485; MDSAP, medical device and medicinal product regulations)

• Identifies key process risks and gaps, drive mitigation and improvement, and provide transparency on QMS performance and best practices.

• Establishes and lead a risk-based QMS audit program across EMEA/LA/AP, deliver management reporting on QMS effectiveness, and support management reviews and continuous improvement.

• Acts as a functional lead the corporate audit team, ensure auditor qualification/re-qualification, and enable effective use of audit management tools integrated with CAPA and reporting systems.

Your Experience

As a Head of Quality Management Systems & Digital Quality  you will have:

• Completed university-level education in a scientific, engineering, pharmaceutical, or related discipline.

• ISO 13485 Lead Auditor Certification.

• Professional membership within a recognised quality, engineering, pharmaceutical, or regulatory body is advantageous.

• 10–15 years of progressive Quality Assurance experience within a regulated industry.

• Minimum of 3 years' hands-on experience in the development, manufacture, control, or distribution of Medical Devices and/or Medicinal Products.

• Proven track record of successfully managing and maintaining ISO 13485-certified Quality Management Systems.

• Demonstrated expertise in Computer System Validation (CSV), digital quality system implementation, and regulatory IT compliance.

• Significant experience leading CAPA, change management, audit programmes, and continuous improvement initiatives.

• Experience supporting regulatory inspections and certification audits.

• Qualified Person (QP) experience in accordance with §15 German Drug Law and EU Directive 2001/83/EC would be highly advantageous.

Your ZEISS Recruiting Team: