Quality Management Systems Specialist
Core
Operational backbone of a regulated Quality Management System (QMS) for software-focused medical devices, ensuring ISO 13485 compliance and driving CAPA, NCR, document control, and audit readiness.
Role type
Quality Management Systems Specialist (Software as a Medical Device)
Builds
Regulated medical software products with complete documentation, traceability, and quality controls
Domain
Medical Devices / Software as a Medical Device (SaMD) / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CAPA/NCR lifecycle management, QMS platform administration, SOP/work instruction authoring, change event coordination, audit preparation, complaint handling oversight, regulatory requirement interpretation (ISO 13485, FDA 21 CFR Part 820, MDSAP), software release quality sign-off
Preferred skills
Qualio platform experience, EU MDR/Health Canada regulatory knowledge, MDSAP renewal audit support, SaMD-specific quality practices (IEC 62304), modern QMS platform implementation, post-market surveillance for AI devices
Technologies
Qualio, QMS platforms, ISO 13485, FDA 21 CFR Part 820, MDSAP, IEC 62304
Responsibilities
Own end-to-end CAPA/NCR lifecycle including root cause investigation and effectiveness verification; Manage active CAPA/NCR queue and provide visibility during quality meetings; Partner with Engineering to ensure timely remediation and documentation; Manage complete document control lifecycle within QMS platform; Coordinate change events from initiation through closure; Draft and maintain SOPs, work instructions, and policies; Serve as Quality representative in software release go/no-go reviews; Own release documentation packages ensuring regulatory traceability; Coordinate internal QMS audits and track findings; Support third-party certification body audits; Monitor regulatory developments; Oversee complaint-handling compliance and data reviews; Administer QMS training activities; Evaluate adoption of new QMS capabilities for SBOM and vulnerability management
Seniority
Mid-level, hands-on IC