Global eQMS Specialist

Straumann Group
Madrid, Spain
30 days ago
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Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience required
3 years minimum
Working hours
Regular working hours
Languages
English
Job source

Tech stack

Audit Trail Software Documentation Data Migration Document Management Systems System Testing Test Scripts Documentation System Information Technology

Job description

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.

Requirements

  • 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

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