Document Control Specialist at Vantedge Medical – Wheeling, Illinois

Document Control Specialist

Full-time | Permanent

Salaried | $70k - $80k

*We are not currently working with third party agencies on this role.

About Us:

Vantedge Medical is the premier metals-based med-tech solutions partner from concept to full-scale manufacturing. We are at the forefront of precision engineering and innovation, specializing in the development and manufacturing of vital components for medical markets such as Robotic Assisted Surgery, Orthopedics, Surgical Instruments, Dental, and more. Our teams work in unison, collaborating and problem-solving to serve the manufacturing needs of the top Medical Original Equipment Manufacturers (OEMs) around the globe. Making a difference in the lives of patients and their families drives us to go above and beyond every day. With a steadfast commitment to advancing medical technology, we take immense pride in the work we do – and have a lot of fun doing it.

About this Opportunity:

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.

Responsibilities:

Document Management:

• 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.

Compliance and Quality Assurance:

• 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.

System Administration:

• 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.

Document Review and Approval:

• Coordinate document review and approval processes, ensuring timely and accurate feedback from stakeholders.
• Track and report on the status of document reviews and approvals.

Record Keeping and Reporting:

• Maintain accurate and up-to-date records of document revisions, approvals, and distribution.
• Generate and distribute reports on document control metrics and compliance status.

Cross-Functional Collaboration:

• 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.

• 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.).
• ISO 13485 / ISO 9001 or related quality management system certification is a plus.
• 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.)
• Office-based with standard working hours. Occasional overtime may be required.
• Interaction with various departments and external stakeholders.