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TI
True Indicating
Quality and Documentation Specialist
Career Insights for Document Control / Management Specialist
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Based on Ohio data
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What they do
A Document Control or Management Specialist manages written and electronic documents for an office or company. Develops or maintains systems for keeping track of documents, including labeling, retrieving, distributing, recovering and destroying documents as needed.
$46,862 / year median in Ohio
+2% projected growth
Job Description
Job Summary We are seeking a detail-oriented and proactive Quality Technician to join our quality assurance team. In this role, you will be responsible for ensuring that products meet our quality standards through precise inspections and adherence to our requirements. Your expertise will help maintain the integrity of our manufacturing processes, support compliance with industry standards such as ISO 13485 and FDA regulations. This position offers an exciting opportunity to play a vital role in delivering high-quality products that meet both customer expectations and regulatory demands. Responsibilities Work with purchasing to inspect and approve incoming materials by confirming specifications, conducting visual and measurement tests, and rejecting unacceptable materials. Inspects in-process production by confirming specifications, conducting visual tests, and communicating required adjustments to the production team. Approves finished products by reviewing batch paperwork, confirming specifications, conducting visual and measurement tests, returning products for re-work, and confirming re-work activities. Maintains product retain documentation and coordinates the physical storage and retrieval of retain samples. Communicates significant issues or developments identified during quality assurance activities. Adhere to document lifecycle and control procedures, and inactive records in accordance with the records retention schedule. Work with Document Owners to develop and maintain documents including but not limited to Standard Operating Procedures, diagrams, meeting minutes, specifications, templates, drawings, approvals, etc. Assist with ensuring employees are trained on documents including Standard Operating Procedures (SOP), Equipment Operating Procedures (EOPs), Workflows (WF), Work Instructions (WI) and policies. Initiate and complete Change Control Records within the QMS related to Controlled Documentation. Performs other duties as assigned by the Director of Quality. Qualifications Bachelor's or Associate's degree preferred; a minimum of 2 years related experience and/or 2 years of direct experience in the medical device manufacturing work environment preferred. Skilled in innovating thinking, problem solving/analysis, planning, and decision making. Excellent written, verbal, and presentation skills. Highly detail-oriented. Experience with Microsoft Office and Google Workspace applications. Excellent communication skills as well as a keen attention to detail. This role is key in ensuring that all products meet established requirements for reliability, compliance, and workmanship. Demonstrated knowledge of