The Quality and Regulatory Compliance Specialist I is responsible for supporting and assisting Clinical Engineering Operations quality and regulatory readiness. This position is responsible for providing assistance and support of the Quality and Regulatory Compliance Program inclusive of audit assistance, risk analysis, monitoring and tracking of CAPA findings, as well as adherence to company policies and procedures to ensure patient safety. The ability of the business to meet its objectives and to remain compliant depends on the output and reliability of the day-to-day operation of Quality and Regulatory Compliance. As such, the Quality and Regulatory Compliance Specialist I must be able to continually adapt to changing business requirements and demand.
Regulation Research and Education Support (25%)
Compliance Program Support (25%)
Audit and CAPA Support (25%)
Operations Support (25%)