Lead and continuously improve the Quality Management System (QMS) to ensure compliance with applicable standards and regulations, including ISO 9001, ISO 13485, FDA Quality Management System Regulation (QMSR), and other relevant requirements.
Manage QMS document control, training, and electronic quality systems, including document changes, controlled records, archival practices, QMS-related training, site eQMS administration, quality metrics and visual management
Lead and support internal and external audits, including audit planning, readiness, coordination, execution, follow-up activities, gap remediation, and timely closure of audit actions to ensure ongoing compliance and inspection readiness.
...
Lead and continuously improve the Quality Management System (QMS) to ensure compliance with applicable standards and regulations, including ISO 9001, ISO 13485, FDA Quality Management System Regulation (QMSR), and other relevant requirements.
Manage QMS document control, training, and electronic quality systems, including document changes, controlled records, archival practices, QMS-related training, site eQMS administration, quality metrics and visual management
Lead and support internal and external audits, including audit planning, readiness, coordination, execution, follow-up activities, gap remediation, and timely closure of audit actions to ensure ongoing compliance and inspection readiness.
...