QMS Systems Engineer

Align Technology; Madrid; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

Align Technology is seeking a QMS Systems Engineer in Madrid, Spain to enhance its global QMS. The successful candidate will ensure compliance and agility within the quality systems, leading integration efforts and harmonization across regions.

This role requires a Bachelor’s degree and 5-7 years of experience in the medical device industry, particularly with QMS processes and eQMS tools. Strong regulatory knowledge, particularly ISO 13485, is essential.

Formación

• 5-7 years of experience in QMS processes and electronic QMS tools in medical devices.
• Solid understanding of regulatory requirements including ISO 13485.
• Experience with CAPA investigations and quality procedures.

Responsabilidades

• Design and maintain global QMS processes and system workflows.
• Manage the global electronic QMS platform and conduct system validation.
• Lead assessment and harmonization of QMS processes across regions.

Conocimientos

QMS process development

eQMS platform configuration

root cause analysis

regulatory knowledge (ISO 13485, FDA 21 CFR Part 820)

team collaboration

Microsoft Office proficiency

Educación

Bachelor’s degree in Engineering or related field

Herramientas

Arena PLM

Descripción del empleo

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 global 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, system configuration, workflow setup, user access, and training.
• Training & Change Management: Support training efforts for QMS processes and electronic quality systems, including the development of training materials and delivery of Train-the-Trainer sessions to ensure consistent knowledge transfer across sites.
• Audit & Compliance Support: Participate in internal audits and support external regulatory inspections by ensuring system readiness, data integrity, and documentation completeness.
• CAPA & Nonconformance Support: Support global CAPA and NC processes by investigating quality issues using root cause analysis techniques, developing effective corrective and preventive actions, and monitoring implementation through effectiveness verification.
• KPIs & Continuous Improvement: Support the development and maintenance of global QMS KPIs and dashboards to enable data-driven quality management and identify opportunities for process improvement.

Department: Legal

Location: EMEA-Spain

What We're Looking For

• Bachelor’s degree in Engineering, Computer Science Quality, Information Technology, Industrial Engineering or a related field or equivalent experience.
• 5-7 years of experience working with QMS process and electronic QMS tools within the medical device industry.
• Hands-on experience with eQMS platform configuration, administration, and validation in a regulated environment (experience with Arena PLM is considered a strong advantage).
• Solid understanding of regulatory requirements including ISO 13485
• The ideal candidate would have knowledge of the following: FDA 21 CFR Part 820, MDSAP, and EU MDR.
• Proven experience creating and updating procedures, leading CAPA investigations, performing root cause analysis and training others on quality processes.
• Excellent presentation and communication skills, with a track record of working effectively with cross-regional stakeholders.
• Ability to work independently and collaborate with global teams and colleagues from diverse backgrounds and cultures, showing respect, adaptability, and a commitment to building a strong quality culture.
• Experience supporting or leading QMS integration activities for new sites, entities, or business units.
• Demonstrated ability to lead CAPA investigations, perform root cause analysis, and drive corrective and preventive actions to closure.
• Experience with QMS KPI development, reporting, and data-driven quality management
• Proficiency in Microsoft Office tools (Excel, Word, PowerPoint).
• Ability to work flexible hours to support collaboration across APAC, EMEA, and Americas regions.
• Creative thinking to make quality engaging for everyone and inspire a culture where every team member is a champion for quality.
• Familiarity with AI-powered quality tools and digital transformation initiatives in QMS.
• Proficiency in English mandatory

Equal Opportunity Statement

Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.