Quality System Specialist
Core
Technical and process owner for electronic Quality Management System (eQMS) workflows, ensuring compliance, validation, and alignment with regulatory requirements in a regulated healthcare environment.
Role type
eQMS System Administrator / Quality Systems SME
Builds
Validated eQMS workflows, reports, KPIs, and dashboards for Complaints, CAPA, Change Control, Training, Document Control, Audits, Supplier Quality, and Risk Management.
Domain
Healthcare / Regulated Quality Systems (Medical Device, Pharmaceutical)
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
eQMS configuration and administration, system validation (URS, FRS, IQ/OQ/PQ), workflow development, regulatory compliance (FDA 21 CFR, ISO), data analysis and reporting, change control management
Preferred skills
Experience with eQMS platforms and reporting tools, knowledge of FDA regulations (21 CFR 210, 211, 820, 803, 806, Part 11) and ISO standards (13485, 14971), MS Office or Google Platform proficiency
Technologies
eQMS platforms, MS Office, Google Platform
Responsibilities
Configure and maintain eQMS modules, workflows, forms, user roles, and permissions; Develop and execute system validation documentation; Design and maintain QMS reports, KPIs, and dashboards; Support internal, customer, and regulatory audits; Provide end-user support and troubleshooting for eQMS workflows.
Seniority
Mid-Senior level (4-6 years experience)