Quality Document Control Specialist

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Full Time Technical Round Rock, TX, US

2 days ago Requisition

Salary Range: $24.00 To $30.00 Hourly

Company History: Fathom is one of the largest digital manufacturing platforms offering on-demand manufacturing in North America. With more than 90 large-platform industrial-grade 3D printing machines and a national footprint with more than 500,000 square feet of manufacturing capacity across 7 facilities, Fathom seamlessly blends in-house capabilities across plastic and metal additive technologies, CNC machining, injection molding & tooling, urethane casting, sheet metal fabrication, and design and engineering.

With over 50 years of industry experience, Fathom is at the forefront of the industry 4.0 digital manufacturing revolution serving clients in the technology, defense, aerospace, medical, automotive and IOT sectors. Fathom’s extensive certifications include ISO 9001:2015, ISO 9001:2015 Design, ISO 13485:2016, AS9100:2016, NIST 800-171 and ITAR.

Position Summary:

The Document Control Specialist is responsible for maintaining an accurate, organized, and audit-ready document and records control system. This position manages controlled documents throughout their lifecycle, reviews and files medical Device History Records (DHRs), coordinates training documentation, and supports supplier quality, monthly cleaning and heat-treat samples, document change control, RMAs, CAPAs, and NCRs. The specialist also supports customer and internal audits by ensuring required records are complete, traceable, current, and readily retrievable.

This role works closely with Quality, Engineering, Operations, and Supply Chain to maintain compliance with company procedures, customer requirements, ISO 9001, and ISO 13485.

Key Responsibilities:

• Administer and maintain the organization’s document control system.
• Coordinate document creation, review, approval, revision, release, distribution, and obsolescence.
• Review controlled documents for accuracy, completeness, formatting, numbering, and required approvals.
• Maintain the master document list and ensure current revisions are available at points of use.
• Maintain complete document change-control records and revision histories.
• Prevent the unintended use of obsolete or superseded documents.
• Control external standards, customer specifications, drawings, and other externally generated documents.
• Review medical Device History Records (DHRs) for completeness, accuracy, and compliance.
• Scan, organize, file, retrieve, and retain completed DHRs and other quality records.
• Coordinate employee training records and monitor training completion.
• Support supplier quality activities, including supplier documentation, evaluations, and performance records.
• Coordinate and document monthly cleaning and heat-treat process samples.
• Support customer and internal audits by preparing records, retrieving objective evidence, and responding to documentation requests.
• Coordinate and maintain Return Material Authorization (RMA) records.
• Support Corrective and Preventive Action (CAPA) and Nonconformance Report (NCR) activities.
• Maintain document security, confidentiality, access permissions, and distribution controls.
• Monitor periodic document reviews and follow up on overdue actions.
• Train employees on document-control requirements and good documentation practices.
• Collaborate with Quality, Engineering, Operations, Supply Chain, and other departments.
• Identify documentation gaps and support corrective actions and process improvements.
• Maintain accurate, traceable, readily retrievable, and audit-ready quality records.

Qualificati…