Quality Systems Specialist

Job description

As a Quality Systems Specialist, you will contribute in the following areas: - Champion continuous improvement efforts within the Quality Management System (QMS) team - Attain a comprehensive understanding of DEKA's products and processes, leveraging this knowledge to drive improvements within the QMS - Coordinate and drive change control activities, including document revisions, ECO processing, distribution, archival, and training completion tracking - Execute and maintain QMS processes to ensure compliance with ISO 13485, FDA QMSR, and internal procedures. - Process owner for document control workflows, ensuring documents are controlled, retrievable, and current - Support CAPA and Internal Audit programs through active involvement in investigations, documentation, tracking of action items, and escalation of overdue actions - Plan and conduct facility inspections and internal audits within defined scope, documenting observations and initiating follow-up actions - Review and approve Quality Records to ensure data integrity and completeness - Collect, analyze, and trend QMS data to support reporting into management review and quality metrics - Maintain and manage QMS databases and e...