Sr Quality Systems Engineer
Core
Develop and maintain quality systems and processes for medical device products in Acute Care & Monitoring, ensuring compliance with regulatory standards and driving corrective actions.
Role type
Senior Quality Systems Engineer
Builds
Medical device products for acute care and monitoring (respiratory therapy, critical care, anesthesia, etc.)
Domain
Healthcare technology / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CAPA ownership and execution, medical device regulatory compliance (FDA, EU MDR, ISO 13485), risk management (ISO 14971), medical device auditing, audit investigation and resolution, cross-functional collaboration
Preferred skills
Project management, root cause analysis techniques, effectiveness check planning, mentoring
Technologies
None stated
Responsibilities
Manage and drive the Corrective and Preventive Action (CAPA) Program, provide oversight into quality programs and processes, support internal and external audits and inspections, investigate and resolve compliance problems or complaints
Seniority
Senior, hands-on IC