Quality System & Compliance Expert
Core
Lead CAPA processes, quality engineering, and validation activities to ensure compliance and drive continuous improvement in medical device manufacturing.
Role type
Quality System & Compliance Expert
Builds
Dialysis-related medical devices (peritoneal and hemodialysis components)
Domain
Medical Devices / Healthcare Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CAPA management, root cause analysis, validation planning, audit support, risk assessment, documentation control, process change management
Preferred skills
Knowledge of single-use sterilized medical devices, cross-functional collaboration, conflict management
Technologies
SAP, SharePoint, NC/CAPA databases, MS Office
Responsibilities
Oversee NC/CAPA intake, investigation, and closure; deliver training on quality databases; prepare performance metrics for management; support validation and change control processes; act as reference point during internal and regulatory audits; ensure compliant documentation and traceability.
Seniority
Mid-level, hands-on IC