Prin Quality Systems Spec
Core
Principal Quality Systems Specialist ensuring global policy alignment with Japanese regulations for medical information systems and security management processes.
Role type
Principal Quality Systems Specialist (Security & Compliance)
Builds
Security management processes, compliance frameworks, and audit readiness for medical information systems.
Domain
Healthcare Technology / Medical Device / Information Security
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Systems/Assurance expertise, ISO 13485 knowledge, QSR knowledge, Japanese regulatory compliance, Security policy implementation, Risk assessment, Audit management, Process improvement, Stakeholder negotiation, Mentoring
Preferred skills
ISO 27001 Lead Implementor certification, ISO 27001 internal audit experience, Project Management experience
Technologies
None explicitly stated
Responsibilities
Align global security policies with Japanese government guidelines; Review system designs for security compliance; Conduct self-audits and prepare evidence for external evaluations; Develop and deliver security training programs; Mentor junior specialists and lead complex process improvement projects.
Seniority
Principal, hands-on IC with strategic influence
