Document Control Specialist

Vantedge Medical • Wheeling, IL

6h • Onsite

About The Position

The Document Control Specialist is responsible for managing and maintaining the document control system in compliance with ISO 13485 & ISO 9001 standards. This role ensures that all documents related to the Quality Management System (QMS) are accurately controlled, updated, and available to relevant stakeholders. The Document Control Specialist will play a key role in supporting regulatory compliance and operational efficiency by managing document revisions, storage, and distribution.

Requirements

• Associate’s degree or equivalent in a related field (e.g., Business Administration, Quality Management).
• Minimum of 3 years of experience in document control or quality management, preferably in a regulated industry (medical devices, pharmaceuticals, etc.).
• In-depth knowledge of ISO 13485 & ISO 9001 standards and document control processes.
• Proficiency in using document management software and systems.
• Strong attention to detail and organizational skills.
• Excellent communication and interpersonal skills.
• Ability to manage multiple tasks and projects simultaneously.
• Proficient in Microsoft 365 (Outlook, Excel, Word, PowerPoint, SharePoint, etc.)

Nice To Haves

• ISO 13485 / ISO 9001 or related quality management system certification is a plus.

Responsibilities

• Maintain and update document control procedures to ensure compliance with ISO 13485 & ISO 9001 requirements.
• Manage the creation, review, approval, and distribution of controlled documents, including policies, procedures, work instructions, and forms.
• Ensure that all documents are properly version-controlled and archived according to retention schedules.
• Ensure that all documents comply with ISO 13485 & ISO 9001 standards and other relevant regulations.
• Perform regular audits of the document control system to identify and address any gaps or non-conformities.
• Assist in the preparation and submission of regulatory documentation as required.
• Administer the electronic document management system (EDMS), including user access, document upload, and metadata management.
• Provide training and support to employees on document control procedures and the use of the EDMS.
• Coordinate document review and approval processes, ensuring timely and accurate feedback from stakeholders.
• Track and report on the status of document reviews and approvals.
• Maintain accurate and up-to-date records of document revisions, approvals, and distribution.
• Generate and distribute reports on document control metrics and compliance status.
• Collaborate with various departments to ensure that document control requirements are met and any issues are resolved promptly.
• Support audits and inspections by providing necessary documentation and addressing any findings related to document control.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree