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
