QMS Systems Engineer

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.

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

About
Your growth and well-being:At Align, every smile matters. We’re committed to helping you thrive by supporting the health, growth, and well-being of our team members through a variety of tools and programs. While specific offerings may vary by location and role, Align employees can typically expect:Health and well-being programs to keep you thriving in both body and mind.Employee-exclusive discounts on Invisalign products.Learning opportunities through online learning resources and support for your individual development plans.Inclusive, global workplace that fosters collaboration, recognition and belonging.Country and/or role specific details will be shared with you by your recruiter during the interview process. Discover Align:We are a global community of game-changers and smart team players, united by our belief in the power of a smile. Our dynamic team of exceptional employees is dedicated to transforming the industry and creating extraordinary outcomes every day.Align’s core values of agility, customer, and accountability are more than words to work by, they are words we live by. The actions we take every day speak to who we are as a company and our focus on being truly impactful. We celebrate our differences, and the many ways we support one another— ultimately creating a more inclusive organization and world as we continue transforming smiles and changing lives.We foster a culture where thinking differently and seeking new experiences are not just encouraged but celebrated. With the Align Mindset, we empower each other, ensuring every voice is heard and valued in an inclusive environment that inspires creativity and collaboration.At Align, we believe in the power of a smile, and we know that every smile is as unique as our employees. As we grow, we are committed to building a workforce rich in diverse cultural backgrounds and life experiences, fostering a culture of open-mindedness and compassion. We live our company values by promoting healthy people and healthy communities, all with the intent of changing millions of lives, one unique smile at a time. As part of our commitment to innovation, Align Technology includes exocad and Cubicure, companies that enhance our offerings and extend our impact to industry transformation.Eager to learn how we embrace our global differences and nurture employee well-being? Explore Align's culture here!Want to discover more about exocad and Cubicure? Click on their names for additional information.