QMS Specialist
Core
Establishing and maintaining a compliant Quality Management System (QMS) for device activities, managing documentation, and ensuring regulatory adherence.
Role type
Mid-level Quality Management System (QMS) Specialist
Builds
Compliant QMS processes, controlled documentation, and audit-ready quality records
Domain
Medical Devices / Regulatory Compliance
Required skills
Document control, QMS documentation management, ISO 13485, FDA QMSR, EU MDR, Root cause analysis, Corrective actions, Non-conformance reporting, Internal audit participation, Risk management, Data analysis
Preferred skills
PLM systems (Windchill), Device Master Record (DMR) management, Continuous improvement methodologies, Agile, Training content development
Technologies
Windchill, PLM systems
Responsibilities
Develop and revise QMS process documents (SOPs, quality manuals), collect and report QMS performance metrics, participate in internal and external audits, identify root causes and recommend corrective actions, maintain and archive quality records, engage in risk management activities, support cross-functional teams on compliance inquiries
Seniority
Mid-level (6–10 years experience)