QMS Manager

ZEISS Group; Lisboa; On-site; EUR 55,000 - 90,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

QMS knowledge

Audit methodologies

Digital QMS systems

Data analytics

Communication skills

Cross-functional collaboration

English fluency

German language (plus)

Education

Bachelors or Masters in engineering or natural sciences

Knowledge of MDSAP, ISO 13485, ISO 9001

Lead Auditor certification (a plus)

Tools

Trackwise

Veeva

Dot compliance

Job description

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