QMS & Compliance Lead (Medical Devices)

ZEISS Group; Lisboa; Presencial; EUR 60 000 - 80 000; Tempo integral

Resumo da oferta

ZEISS Group in Lisbon, Portugal is seeking a QMS Manager to lead maintenance and improvements of the QMS in a regulated environment. You will drive audits, data reporting for management reviews, and oversee digital QMS tools while ensuring CSV compliance.

Ideal candidates have 3–5 years in quality management within medical devices or related sectors, with strong analytical, communication, and cross-functional collaboration skills. Travel occasionally may be required.

Qualificações

• Education includes degree in engineering or sciences with regulatory knowledge.
• Familiar with MDSAP, ISO 13485/9001 and GxP requirements.
• Lead Auditor certification is a plus.

Responsabilidades

• Maintain and improve QMS compliance with ISO 9001 and ISO 13485.
• Plan, coordinate and support internal and external audits.
• Collect and analyze QMS data for management review and CRB inputs.
• Support digital QMS tools and CSV/compliance requirements.
• Drive cross-functional QMS improvements and CAPA initiatives.
• Provide QMS training and guidance to stakeholders.
• Coordinate with notified/certification bodies and auditors.

Conhecimentos

Data analysis

Problem solving

Communication

Stakeholder management

Cross-functional collaboration

Fluent in English

German knowledge (nice to have)

Formação académica

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

Descrição da oferta de emprego

ZEISS Group in Lisbon, Portugal is seeking a QMS Manager to lead maintenance and improvements of the QMS in a regulated environment. You will drive audits, data reporting for management reviews, and oversee digital QMS tools while ensuring CSV compliance.

Ideal candidates have 3–5 years in quality management within medical devices or related sectors, with strong analytical, communication, and cross-functional collaboration skills. Travel occasionally may be required.