QMS Manager

About the role

ZEISS is seeking a QMS Manager to join its Lisbon team. You will be responsible for maintaining and continuously improving the Quality Management System to ensure compliance with ISO 9001, ISO 13485 and other regulatory standards.

Key responsibilities

• Support the maintenance and improvement of the QMS, ensuring compliance with ISO 9001, ISO 13485 and MDSAP.
• Identify process gaps, conduct risk assessments and contribute to corrective and preventive actions (CAPA).
• Plan, coordinate and execute internal and external audits using a risk‑based approach, prepare audit documentation and track findings to closure.
• Collect, analyse and report QMS performance data for management review and support management review meetings.
• Prepare inputs for Change Review Board meetings and track quality‑relevant changes.
• Design, implement, validate and maintain digital quality tools (eQMS, RIMS) and ensure Computer System Validation compliance.
• Analyse audit outcomes and quality metrics to drive continuous improvement.
• Provide training on QMS processes and tools and advise stakeholders on best practices.
• Coordinate with notified bodies, certification bodies and external auditors.

Required profile

• Bachelor’s or Master’s degree in engineering, natural sciences or a related field.
• 3–5 years of experience in quality management within a regulated industry (medical devices, pharmaceuticals, etc.).
• Knowledge of ISO 9001, ISO 13485, MDSAP and GxP requirements.
• Experience with QMS processes, audits and digital quality systems.
• Strong analytical, problem‑solving and stakeholder‑management skills.
• Fluent English; German is a plus.

Required skills

• ISO 9001
• ISO 13485
• MDSAP
• GxP
• Computer System Validation (CSV)
• eQMS
• RIMS solutions
• Trackwise
• Veeva
• Dot compliance