QMS Systems Engineer

Key Responsibilities

• 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.

Skills, Knowledge & Expertise

• 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