Description

This position is ideal for experienced professionals with strong QMS and electronic quality system expertise to join the Global QMS team as a QMS Systems Engineer. You will play a key role in the integration of business entities into Align QMS ecosystem, support the harmonization of quality processes across regions, optimize system configurations, and enable data-driven decision-making. Partnering with cross-functional teams, you will ensure our integral QMS is not only compliant but also agile, scalable, and digitally empowered — aligned with business needs and supporting regulatory readiness across the organization. This role helps create standardized, consistent and digital quality processes within Align QMS, supporting the success of the business.

Role expectations
- QMS Process Development & System Configuration: Design, develop, and maintain global QMS processes and translate them into electronic QMS system workflows, templates, and documentation across key areas including Change Management, CAPA, Nonconformance, Internal Audits,



and Document Control using tools such as Arena PLM or similar eQMS platforms.
- Electronic QMS Tool Management: Manage and maintain the global electronic QMS platform, including user access, system configuration, and ongoing functionality to support QMS processes across the organization. Lead system validation and verification activities (IQ/OQ) for configuration changes and software releases.
- Global Process Harmonization: Lead the assessment and harmonization of QMS processes across sites and regions by reviewing site-specific procedures, identifying gaps, and aligning them with global QMS standards and regulatory requirements.
- New Entity QMS Integration: Evaluate existing QMS processes, documentation, and tools of new or existing business entities to define integration requirements. Lead collaboration with QA leaders and subject matter experts to design and execute integration plans, including document migration, sys

📌 QMS Systems Engineer (Madrid)
🏢 Align Technology
📍 Madrid