QMS Manager

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 is an internationally leading technology enterprise operating in the optics and optoelectronics industries generating more than 11.8 billion euros in revenue with around 46,000 employees across 50 countries around the globe. We’re looking for a QMS Manager to join our team in Lisbon, Portugal.

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

You Will Have

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