Global eQMS Specialist

Institut Straumann AG

Madrid

Presencial

EUR 55.000 - 85.000

Jornada completa

Hace 9 días
Generador de candidaturas

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Descripción de la vacante

Straumann Group in Madrid is seeking a Global eQMS Specialist to operate, maintain, and improve our electronic Quality Management System. You will collaborate across Quality, IT, and site teams to keep the platform reliable, compliant, and user-friendly.

This role combines user support with lifecycle validation, testing, and documentation, contributing to global rollouts and process improvements that enhance quality and user experience.

Formación

  • Bachelor’s degree in Quality, Engineering, IT or a related field.
  • At least three years of relevant professional experience.
  • Experience with electronic quality management systems.
  • Experience with validation and testing methods.
  • Experience supporting users in an international environment.
  • Knowledge of key QMS processes: Document Control, Training Management, CAPA, Change Management, Audit Management, Design Control, Complaints.
  • Fluent written and spoken English.

Responsabilidades

  • Provide global support for eQMS users and Quality teams, resolving incidents and requests.
  • Maintain system data, content, templates, groups, and configurations.
  • Define and document user requirements; maintain validation docs and test scripts.
  • Plan and coordinate user acceptance testing; support validated state throughout lifecycle.
  • Coordinate testing, validation, deployment, and post-implementation checks for enhancements.
  • Develop training materials and user documentation for role-specific needs.
  • Support global module rollouts across readiness, testing, migration and go-live.
  • Gather user feedback and translate needs into practical improvements.
  • Communicate priorities, timelines, risks clearly with global stakeholders.

Conocimientos

eQMS expertise
Validation methods
Cross-functional collaboration
Technical communication
English fluent
Quality processes

Educación

University degree in Quality

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

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