Audit-Ready Quality Document Controller

Fathom Digital Manufacturing; Round Rock (TX); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Health Benefits

401k Plan

Paid time off

Employee discounts

Job summary

Fathom Digital Manufacturing is seeking a Document Control Specialist to maintain an accurate, audit-ready document system and manage DHRs. You will coordinate document life cycles, training records, and quality records across Quality, Engineering, Operations, and Supply Chain.

The role supports audits, CAPA/NCR activities, supplier quality, and change control, ensuring GDP and retention requirements are met within a regulated manufacturing environment.

Qualifications

• Three to five years of document control or quality-system experience in a regulated manufacturing environment.
• Working knowledge of ISO 9001 and ISO 13485 requirements.
• Experience reviewing and maintaining medical Device History Records (DHRs).
• Experience with controlled-document creation, revision, approval, release, distribution, retention, and obsolescence.
• Familiarity with document change control, revision histories, and electronic document management systems.
• Experience supporting customer, internal, and certification audits.
• Familiarity with CAPA, NCR, RMA, supplier quality, and training-record processes.
• Understanding of GDP and quality-record retention requirements.

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• Prevent the unintended use of obsolete or superseded documents.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 RMA records.
• Support CAPA and NCR activities.
• Maintain document security, confidentiality, and access controls.
• Monitor periodic document reviews and overdue actions.
• Train employees on document-control requirements and GDP.
• Collaborate with Quality, Engineering, Operations, Supply Chain, and management.
• Identify documentation gaps and support corrective actions.

Skills

Attention to detail

Organization

Written communication

Verbal communication

Multitasking

Collaborative teamwork

Education

Bachelor's or Associate degree in Quality/Engineering/Business

High school diploma required

Tools

MS Word

MS Excel

MS Outlook

Adobe Acrobat

Document scanning systems

Job description

Fathom Digital Manufacturing is seeking a Document Control Specialist to maintain an accurate, audit-ready document system and manage DHRs. You will coordinate document life cycles, training records, and quality records across Quality, Engineering, Operations, and Supply Chain.

The role supports audits, CAPA/NCR activities, supplier quality, and change control, ensuring GDP and retention requirements are met within a regulated manufacturing environment.