ZEISS
optics and optoelectronics
QMSManager
Neural analysis suggests this role is
optimal for Mid candidates.
“QMS Manager at ZEISS. Skills: QMS maintenance and improvement, audit program support, Management reporting, Digital quality systems, Continuous improvement, Training and support, External interfaces. 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)”
What You'll Achieve.
ensure compliance with standards such as ISO 9001 and ISO 13485; Identify process gaps; support risk assessments; contribute to implementation of corrective and preventive actions (CAPA); ensure timely follow-up and closure of audit actions; ensure data integrity and compliance with Computer System Validation (CSV) requirements; identify improvement opportunities
Industry & Context.
data analytical and problem-solving skills
Willingness to travel occasionally, Ability to work across different time zones and functions, Adherence to company policies and quality standards
What They're Looking For.
Must Have
Bachelor’s or Master’s degree in engineering, natural sciences, or related field, Knowledge of MDSAP, ISO 13485 and ISO 9001 standards, GxP requirements, 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, Understanding of QMS processes and regulatory requirements, Basic knowledge of audit methodologies and CAPA processes, data analytical and problem-solving skills, Good communication and stakeholder management skills, Ability to work in cross-functional and international environments
Nice to Have
Lead Auditor certification is a plus, 3-5 years Computer System Validation experience is an advantage, Deep understanding with electronic QMS systems e. g. Trackwise, Veeva, Dot compliance etc., Fluent in German is a plus
What You'll Do.
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), 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, 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, Support design, implementation, validation, and maintenance of digital RA/QMS tools and systems (e.
, eQMS, RIMS solutions), Ensure data integrity and compliance with Computer System Validation (CSV) requirements, Analyze audit outcomes, deviations, and quality metrics to identify improvement opportunities, Support cross-functional initiatives to enhance QMS processes (e.
, NC/ CAPA, document control, complaints, deviation permits), Support training activities related to QMS processes and tools (e.
eQMS, RIMS), Provide guidance to stakeholders on QMS requirements and best practices, Support coordination with notified bodies, certification bodies, and external auditors.
How You'll Work.
Team & Collaboration
cross-functional coordination; vendor/stakeholder management; Ability to work in cross-functional and international environments; Support cross-functional initiatives to enhance QMS processes; Provide guidance to stakeholders on QMS requirements and best practices; Support coordination with notified bodies, certification bodies, and external auditors
Communication Scope
Good communication and stakeholder management skills
Process & Methodology
process management, resource planning
Full 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 n
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