QMS Manager – Quality Management System Lead

About the role

Zeiss is seeking an experienced QMS Manager to support and continuously improve its Quality Management System in Lisbon. You will ensure compliance with ISO 9001, ISO 13485 and related standards while driving digital quality initiatives.

Key responsibilities

• Maintain and improve the QMS, identifying gaps, supporting risk assessments and CAPA implementation.
• Plan, coordinate and execute internal and external audits using a risk‑based approach, track findings and ensure timely closure.
• Collect, analyse and report QMS performance data for management review and support Change Review Board meetings.
• Design, validate and maintain digital quality tools such as eQMS and RIMS, ensuring CSV compliance.
• Analyse audit outcomes and quality metrics to identify continuous improvement opportunities.
• Provide training on QMS processes and tools, and guide 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 related field.
• Knowledge of MDSAP, ISO 13485, ISO 9001 and GxP requirements; Lead Auditor certification is a plus.
• 3–5 years of quality management experience in a regulated industry (medical devices, pharmaceuticals, etc.).
• Hands‑on experience with QMS processes, audits and digital quality systems.
• Experience with Computer System Validation (CSV) is advantageous.
• Strong analytical, problem‑solving and communication skills; ability to work cross‑functionally and internationally.
• Fluent in English; German is a plus.

Required skills

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