Quality Management System (QMS) Engineer

About the role

This role focuses on ensuring compliance with medical device regulations and standards, managing quality management system (QMS) activities, and supporting organizational quality initiatives across audits, documentation, change control, and continuous improvement.

Key responsibilities

• Ensure compliance with medical device regulations and standards across audits, CAPA, change control, documentation, records, and training
• Plan, coordinate and support internal/external audits, including reviewing technical documents and addressing audit findings
• Manage and coordinate QMS, design and process changes, ensuring proper review, validation/verification, documentation and implementation
• Administer and monitor CAPA activities, including root cause analysis, corrective actions, effectiveness checks and reporting
• Maintain controlled QMS documents and quality records, including distribution, retrieval, archival and record management
• Develop QMS training materials, provide system/user training, manage training records and support staff certification and onboarding
• Track QMS KPIs, training status, audit/CAPA/change-control progress and support management review meetings
• Work with global QMS teams and process owners to harmonize processes, improve QMS systems, and support quality-related projects and initiatives

About you

• Technical/scientific degree with 3+ years of Quality experience in a regulated industry, preferably medical devices/pharmaceuticals
• Familiar with cGMP, document/change control, CAPA, Good Documentation Practices and basic problem-solving tools
• Proficient in Microsoft Office; experience with SAP, LMS, MES or electronic document systems is an advantage
• Strong communication, attention to detail, organization, time management, and ability to work independently and in a team