Overview
Head of Quality Management Systems & Digital Quality Jobs in Lisbon, Portugal at ZEISS Group
Title: Head of Quality Management Systems & Digital Quality
Company: ZEISS Group
Location: Lisbon, Portugal
ZEISS is technology and innovation. Founded in Germany in 1846, we’re an internationally leading technology enterprise operating in the optics and optoelectronics industries generating more than 11.8 billion Euros in revenue with around 46,000 employees across 50 countries around the globe.
As a company wholly owned by a foundation, ZEISS is rooted in and committed to responsibility in all its activities. Therefore, 15% of revenue is currently invested in science and R&D. As the pioneer of scientific optics, we continue to challenge the limits of human imagination. With our passion for excellence we create value for our customers and inspire the world to see in new ways. We’re looking for a Head of Global Management Systems & Digital Quality to join us in Lisbon, Portugal.
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.
Apply now to take the next step in joining ZEISS, where you can push technological boundaries, shape markets and contribute to the advancement of society.
Your ZEISS Recruiting Team:
Kate Campbell
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Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, ideology, disability, age or sexual orientation and identity.
