Director of Quality
Core
Build, implement, and lead an ISO 13485-compliant quality management system for continuous potassium monitoring products advancing through clinical development and commercialization.
Role type
Senior, hands-on Director of Quality
Builds
Continuous potassium monitoring products
Domain
Medical devices / Diagnostics / Connected health
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 13485 compliance, QMS roadmap planning, risk-based remediation, electronic QMS administration, design controls (DHF, verification, validation), supplier quality, CAPA management, audit readiness, change leadership
Preferred skills
Advanced quality or regulatory certification
Technologies
Electronic quality management systems
Responsibilities
Own quality strategy and QMS roadmap, assess compliance gaps and lead remediation, establish quality governance and document control, implement design controls, partner with regulatory teams on submission evidence, mature core QMS processes (supplier quality, training, nonconformance, audits), support clinical operations with quality oversight, investigate quality issues and drive corrective actions, coach teams and build future quality capacity
Seniority
Senior, hands-on IC
