QMS Manager: Digital Quality & Compliance Lead

Carl Zeiss Vision Portugal S.A.; Lisboa; Presencial; EUR 55 000 - 85 000; Tempo integral

Resumo da oferta

Carl Zeiss Vision Portugal S.A. is seeking a QMS Manager to lead the maintenance and continuous improvement of the quality management system, aligning with ISO 9001 and ISO 13485, and supporting CAPA, audits and data-driven improvements in a global, cross-functional context.

You will drive risk assessments, manage internal and external audits, prepare documentation, and contribute to management reviews and change processes. Fluent English is required; German is a plus, with occasional travel.

Qualificações

• Bachelor’s or Master’s degree in engineering, natural sciences, or related field.
• Knowledge of MDSAP, ISO 13485 and ISO 9001 standards, GxP requirements.
• Lead Auditor certification is a plus
• 3–5 years of experience in Quality Management in a regulated industry (medical devices, pharmaceuticals, or similar)

Responsabilidades

• QMS maintenance and improvement
• Support the maintenance and continuous improvement of the QMS to ensure compliance with standards such as ISO 9001 and ISO 13485
• Identify process gaps, support risk assessments, and contribute to implementation of CAPA
• Audit program support
• Manage planning, coordination, and execution of internal and external audits following a risk-based approach
• Prepare, support audit documentation, track findings, and ensure timely follow-up and closure of audit actions
• Management reporting: Collect, analyze, and prepare QMS performance data and reports for management review
• Support preparation and documentation of management review meetings and follow-up actions
• Prepare inputs for and manage Change Review Board (CRB) meetings, ensuring proper evaluation, meeting documentation, and tracking of quality-relevant changes
• Digital quality systems: Support design, implementation, validation, and maintenance of digital RA/QMS tools and systems (e.g., eQMS, RIMS solutions)
• Ensure data integrity and compliance with Computer System Validation (CSV) requirements
• Continuous improvement: Analyze audit outcomes, deviations, and quality metrics to identify improvement opportunities
• Support cross-functional initiatives to enhance QMS processes (e.g., NC/ CAPA, document control, complaints, deviation permits)
• Training and support: Support training activities related to QMS processes and tools (e.g. eQMS, RIMS) & Provide guidance to stakeholders on QMS requirements and best practices
• External interfaces: Support coordination with notified bodies, certification bodies, and external auditors

Conhecimentos

Data analysis

Problem solving

Stakeholder management

Cross-functional work

Quality systems

Formação académica

Bachelor’s or Master’s in engineering or natural sciences

Ferramentas

Trackwise

Veeva

Dot compliance

Descrição da oferta de emprego

Carl Zeiss Vision Portugal S.A. is seeking a QMS Manager to lead the maintenance and continuous improvement of the quality management system, aligning with ISO 9001 and ISO 13485, and supporting CAPA, audits and data-driven improvements in a global, cross-functional context.

You will drive risk assessments, manage internal and external audits, prepare documentation, and contribute to management reviews and change processes. Fluent English is required; German is a plus, with occasional travel.