Document Control Specialist

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.

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.

• Standard Health, Dental, Vision Benefits.
• Generous PTO.
• 401K Match.