QMS Compliance Lead (ISO 9001/13485) - Lisbon

ZEISS Group; Lisboa; In loco; EUR 55.000 - 90.000; Tempo pieno

Descrizione del lavoro

ZEISS Group in Lisbon, Portugal, is seeking a QMS Manager to lead the maintenance and improvement of the quality management system. The role involves audit program management, data-driven reporting, and cross-functional collaboration in a regulated environment.

You will support digital QMS tools, ensure CSV-compliant data integrity, and drive CAPA/NC processes with international teams. Fluency in English is required; German is a plus.

Competenze

• 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.

Mansioni

• QMS maintenance and improvement to ensure ISO 9001/13485 compliance.
• Audit program planning, coordination, and execution for internal/external audits.
• Prepare management reports and support CRB meetings.
• Support digital quality tools and CSV-compliant data integrity.
• Analyze quality metrics and drive continuous improvement initiatives.
• Provide QMS training and guidance to stakeholders.
• Coordinate with notified/certification bodies and auditors.

Conoscenze

QMS knowledge

Audit methodologies

Digital QMS systems

Data analytics

Communication skills

Cross-functional collaboration

English fluency

German language (plus)

Formazione

Bachelors or Masters in engineering or natural sciences

Knowledge of MDSAP, ISO 13485, ISO 9001

Lead Auditor certification (a plus)

Strumenti

Trackwise

Veeva

Dot compliance

Descrizione del lavoro

ZEISS Group in Lisbon, Portugal, is seeking a QMS Manager to lead the maintenance and improvement of the quality management system. The role involves audit program management, data-driven reporting, and cross-functional collaboration in a regulated environment.

You will support digital QMS tools, ensure CSV-compliant data integrity, and drive CAPA/NC processes with international teams. Fluency in English is required; German is a plus.