Global eQMS Specialist

Straumann Group; Madrid; Presencial; EUR 55.000 - 70.000; Jornada completa

Descripción de la vacante

Straumann Group is seeking a Global eQMS Specialist to operate, maintain, and improve the electronic Quality Management System across Quality, IT, and site teams. You will coordinate validation, training, documentation, and system enhancements in a global context.

In this role you will support users, manage configurations, and drive improvements to processes, ensuring compliant digital workflows and robust audit trails worldwide. Fluency in English is essential.

Formación

• University degree or equivalent in Quality, Engineering, IT, or related field.
• Minimum three years of relevant experience.
• Experience with electronic Quality Management System and validated digital platform.
• Familiarity with validation and testing methods.
• Experience supporting users in an international environment.
• Strong written and verbal communication skills, with fluency in English.

Responsabilidades

• Provide global support for eQMS users and Quality teams, investigating incidents and service requests.
• Maintain approved system data, content, templates, groups, configurations, and routine checks.
• Define and document user requirements and maintain validation documentation.
• Plan, coordinate, and execute user acceptance testing and support the eQMS in a validated state.
• Assess improvement requests and coordinate testing, validation, deployment, and post-implementation checks.
• Develop and maintain training materials, user documentation, learning content, and self-service resources.
• Support global module rollouts across business readiness, testing, migration, training, go-live, and post-go-live activities.
• Gather user feedback and translate recurring needs into practical improvements.
• Communicate technical topics clearly to stakeholders with updates on priorities, timelines, and risks.

Conocimientos

Quality systems

eQMS

Regulatory compliance

Validation testing

Cross-functional collaboration

Global stakeholder management

Educación

Bachelor's degree in Quality/Engineering/IT

Herramientas

ETQ Reliance

Descripción del empleo

Are you ready to unlock your potential? At Straumann Group we’re on an exciting journey of growth, innovation, and impact - driven by our mission to improve oral health and transform millions of lives worldwide. United by purpose, we bring our best selves to work every day, embracing a high-performance, player-learner culture that inspires collaboration, curiosity, and ambition. Here, you’ll have the opportunity to take charge of your own career, harnessing your skills, passion, and enthusiasm for learning to continually grow and progress. Together, we’re not just shaping brighter smiles, we’re unlocking the potential of people everywhere, including our own.

Introduction

As a Global eQMS Specialist, you’ll help operate, maintain, and continuously improve Straumann Group’s electronic Quality Management System (eQMS). You’ll work across Quality, IT, process ownership, site teams, external consultants, and system partners to keep the platform reliable, compliant, user-friendly, and aligned with business and Quality Management System requirements.

This role combines global user support with system lifecycle activities, computerized system validation, training, documentation, stakeholder coordination, and improvement initiatives. You’ll have an opportunity to contribute to global rollouts and enhancements that improve both the quality of our processes and the experience of the people using them.

Your Role

You Will

• Provide global support for eQMS users, Quality teams, process owners, and subject matter experts, investigating and resolving incidents and service requests.
• Maintain approved system data, content, templates, groups, configurations, and routine operational checks.
• Define and document user requirements and maintain validation documentation, including user requirements specifications, test scripts, traceability records, and supporting evidence.
• Plan, coordinate, and execute user acceptance testing and support the eQMS in a validated state throughout its lifecycle.
• Assess improvement requests and coordinate the testing, validation, deployment, and post-implementation checks for system enhancements and releases.
• Develop and maintain training materials, user documentation, learning content, and self-service resources, including role-specific and refresher training.
• Support global module rollouts across business readiness, testing, migration, training, go-live, and post-go-live activities.
• Gather user feedback and translate recurring needs into practical improvements to the system, content, and user experience.
• Communicate technical topics clearly, providing transparent updates on priorities, timelines, issues, dependencies, and risks while building effective relationships with global stakeholders.

Your Profile

Essential

• University degree or equivalent in Quality, Engineering, Information Technology, or another relevant scientific discipline.
• At least three years of relevant professional experience.
• Experience supporting or implementing an electronic Quality Management System or comparable regulated digital platform.
• Experience with computerized system validation requirements and testing methods.
• Experience supporting users in an international environment.
• Good understanding of eQMS and controlled digital processes, including relevant Quality processes such as Document Control, Training Management, Nonconformance, CAPA, Change Management, Audit Management, Design Control, and Complaints.
• Working knowledge of computerized system validation principles and risk-based testing.
• Ability to understand workflows, user roles, access concepts, electronic records, audit trails, and system dependencies.
• Strong written and verbal communication skills, with the ability to explain complex system topics clearly.
• Fluent written and spoken English.

Nice to have

• Experience in the medical device, pharmaceutical, life sciences, or another regulated industry.
• Experience with system rollouts, lifecycle activities, data migration, or system enhancements.
• Additional education or certification in Quality Management, computerized system validation, or digital transformation.
• Familiarity with service-management and validation-documentation tools.
• Experience with the tool ETQ Reliance is an advantage

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability

21978