Manage and maintain ISO 13485:2016-compliant documentation in the IQMS system, including quality plans, production and supplier records, inspection reports, calibration logs, batch records, and COCs. Verify paperwork accuracy, support MRB activities and calibration coordination, and identify process improvements to ensure document traceability and regulatory compliance.
The Document Control Specialist is responsible for managing and maintaining the integrity of documentation and record-keeping in compliance with ISO 13485:2016 standards. This role involves handling quality plans, production documentation, inspection reports, calibration activities, and supplier-related records, ensuring that all documentation is accurate, up-to-date, and readily accessible within the IQMS system.
Duties:
- Manage and update quality plans, in-process documents, and drawings in the IQMS system.
- Ensure accurate and timely upload of supplier-related documents to the IQMS system.
- Review and save last-shot paperwork from production runs.
- Verify batch production records for completeness and accuracy.
- Perform COC (Certificate of Conformance) verification and authorization.
- Ensure proper storage and traceability of material certificates.
- Verify and save inspection reports for compliance with company standards.
- Handle supplier-related documentation, ensuring timely uploads and updates in the IQMS system.
- Maintain compliance with ISO 13485:2016 requirements and company quality standards.
- Identify opportunities for process improvement in document control and record management systems.
When Required:
- Participate in Material Review Board (MRB) activities, including quarantine, meeting coordination, disposition, and record-keeping.
- Coordinate calibration activities for tools and ensure up-to-date calibration records.
Requirements
Skills and Requirements:
- High school diploma or equivalent required;
- Ability to read part drawings and translate dimensional and cosmetic requirements from a drawing into written work instructions for machine operators.
- One to three years of experience in document control, preferably in a manufacturing environment.
- Experience working in an ISO 13485:2016-certified company is a plus.
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
- Strong attention to detail and organizational skills.
- Ability to work collaboratively across departments and with external suppliers.
- Familiarity with quality management processes.
- Must be able to read, write, and verbally communicate in English.
Benefits
Standard Health, Dental, Vision Benefits.
Generous PTO.
401K Match.
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