Document Control Administrator

ESSENTIAL FUNCTIONS

Document Management: Manage document lifecycle activities including revising, creating and obsoleting documents. Maintaining and organizing both physical and digital documents, ensuring they are up-to-date, accurate, and easily accessible.

Compliance Assurance: Ensure all documents comply with company policies, industry standards, and regulatory requirements such as FDA 21 CFR Part 820 and ISO 13485.

Document Distribution: Manage document revisions, including tracking changes and maintaining version control.

Database Maintenance: Update and maintain the document management system (SAP) and databases (as required), including but not limited to specification deviations and experimental work orders (EWO).

Change Management: Facilitate document updates related to engineering changes, process improvements, and corrective actions. Acting back up for the change management coordinator.

Auditing and Reporting: Conduct regular audits to verify document accuracy and generate reports on document control activities.

Training and Support: Train team members on document control processes. Works closely with cross-function teams, including engineering, quality assurance and manufacturing to address document-related needs.

Process Optimization: Develop and refine document control processes to improve efficiency and compliance within document control.

Training System Support: Training system (C2C) department learning administrator activities which include but are not limited to updating curriculums following ECO releases

ADDITIONAL RESPONSIBILITIES

Additional responsibilities as assigned

EXPERIENCE AND KNOWLEDGE

Minimum of 1 year experience in similar role

The Document Control Administrator should have a strong working knowledge of the following:

Microsoft Word

Microsoft Excel