Overview We are seeking a highly organized and detail-oriented Document Control Specialist to join our dynamic team. In this pivotal role, you will oversee the management, review, and control of critical documentation across various departments, ensuring compliance with industry standards and regulatory requirements. Your expertise will support quality management systems, facilitate seamless document workflows, and uphold the integrity of our documentation processes. The ideal candidate will possess strong technical proficiency, excellent organizational skills, and a proactive approach to document management within a regulated environment. Duties Implement and maintain document control procedures aligned with

ISO 13485, ISO

9001, and FDA regulations to ensure compliance across all documentation activities. Manage electronic document management systems such as SharePoint and other project management software to organize, store, and retrieve documents efficiently. Review, verify, and approve technical documents for accuracy, completeness, and compliance with regulatory and legal standards. Coordinate document workflows across cross-functional teams to facilitate timely review, approval, and distribution of controlled documents. Maintain meticulous filing systems—both digital and physical—ensuring easy access while safeguarding confidentiality. Conduct regular audits of documents to verify adherence to quality management protocols and regulatory standards. Assist in data entry, proofreading, and data management tasks related to document records. Support document revision processes by tracking changes and maintaining version control. Collaborate with engineering, quality assurance, regulatory affairs, and production teams to ensure consistent documentation practices. Prepare reports on document status, review cycles, and compliance metrics for management review. Experience Proven experience in document control within the engineering or pharmaceutical industry environment. Familiarity with

ISO 13485

(medical devices), ISO 9001 (quality management), FDA regulations, and pharmaceutical regulatory compliance standards. Demonstrated proficiency with document management systems such as SharePoint or equivalent platforms. Strong understanding of document workflow management, filing systems, and records management best practices. Experience with technical writing, proofreading, and ensuring document compliance is highly desirable. Excellent organizational skills with the ability to manage multiple priorities simultaneously. Effective cross-functional communication skills to coordinate between diverse teams. Prior administrative experience involving data entry, project management software utilization, and technical documentation is advantageous. Join our team as a Document Control Specialist to contribute significantly to maintaining rigorous documentation standards that support our commitment to quality excellence. Your expertise will help drive operational efficiency while ensuring full compliance with industry regulations.

Pay:

$20.00 - $21.00 per hour

Benefits:

Health insurance

Work Location:

In person