Quality System Specialist
Core
Support the development and maintenance of the quality management system for medical devices to ensure regulatory compliance and receive clearance/certification.
Role type
Quality System Specialist
Builds
Quality management system (QMS) and electronic documentation systems
Domain
Medical devices / Regulatory compliance
Required skills
Document control, Change management, Regulatory compliance, Audit coordination, Electronic document management, Quality planning
Preferred skills
FDA/ISO regulatory knowledge, Matrix organization management, Project management, Risk management
Technologies
Electronic documentation systems, Microsoft Office Suite
Responsibilities
Manage QMS document lifecycle and changes, Facilitate engineering documentation management, Coordinate internal and external audits, Support GMP and GDP within Quality organization, Provide guidance on electronic management processes, Execute QMS modifications
Seniority
Junior to Mid-level (0-2 years experience)