Head of Quality Management Systems & Digital Quality

About the role

ZEISS is seeking a senior leader to drive the strategic development and continuous improvement of its global Quality Management System (QMS) for medical devices. Based in Lisbon, you will ensure regulatory compliance, integrate digital solutions, and lead a worldwide team of quality professionals.

Key responsibilities

• Provide governance over the Integrated QMS across EMEA, LATAM and APAC, ensuring alignment with ISO 9001, ISO 13485, MDSAP and other medical device regulations.
• Identify process risks and gaps, drive mitigation actions, and deliver transparent performance reporting.
• Establish and lead a risk‑based QMS audit program, produce management reports, and support continuous improvement initiatives.
• Act as functional lead for the corporate audit team, manage auditor qualification/re‑qualification, and oversee audit management tools integrated with CAPA and reporting systems.

Required profile

• University degree in a scientific, engineering, pharmaceutical or related discipline.
• ISO 13485 Lead Auditor certification.
• 10–15 years of progressive Quality Assurance experience in a regulated industry.
• Minimum 3 years of hands‑on experience with development, manufacture, control or distribution of medical devices or medicinal products.
• Proven track record managing ISO 13485‑certified QMS and expertise in Computer System Validation (CSV) and digital quality solutions.

Required skills

• ISO 13485
• ISO 9001
• MDSAP
• Computer System Validation (CSV)
• CAPA
• Audit management tools