QMS Manager

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

Your Role

As a QMS Manager your role will involve:

• 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 corrective and preventive actions (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

Your Profile

• Education / Professional Certification
• 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
• Experience 3–5 years of experience in Quality Management in a regulated industry (medical devices, pharmaceuticals, or similar)
• Experience with QMS processes and audits
• 3-5 years proactive collaboration in digital quality systems and 3-5 years Computer System Validation experience is an advantage
• Knowledge / Skills / Other characteristics
• Understanding of QMS processes and regulatory requirements
• Basic knowledge of audit methodologies and CAPA processes
• Deep understanding with electronic QMS systems e.g. Trackwise, Veeva, Dot compliance etc.
• Strong data analytical and problem-solving skills
• Good communication and stakeholder management skills
• Ability to work in cross-functional and international environments
• Fluent in English; German is a plus
• Working conditions & Other Attributes
• Willingness to travel occasionally
• Ability to work across different time zones and functions
• Adherence to company policies and quality standards

Your ZEISS Recruiting Team: Joe Taroni

Step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people. In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together.

Join us today. Inspire people tomorrow. Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.