Quality Document Control Specialist – ISO 9001/13485

Fathom Mfg; Round Rock (TX); On-site; USD 33,000 - 41,000; Full time

Benefits offered by this job

Health benefits

Life insurance

Disability insurance

Paid time off

401k Plan

Discounts on products and services

Job summary

Fathom is seeking a Document Control Specialist to maintain an audit-ready records system, manage controlled documents, review DHRs, and coordinate training documents in a regulated manufacturing environment.

You will collaborate with Quality, Engineering, Operations, and Supply Chain to ensure ISO 9001/13485 compliance, change control, and training-record processes while supporting audits.

Qualifications

• High school diploma or equivalent; degree preferred.
• 3–5 years of document control or quality-system experience in regulated manufacturing.
• Working knowledge of ISO 9001 and ISO 13485.
• Experience with DHRs and controlled-document lifecycle.
• GDP and quality-record retention understanding.
• ASQ cert or formal document-control training preferred.

Responsibilities

• Administer and maintain the document control system.
• Coordinate document creation, revision, release, and obsolescence.
• Review documents for accuracy, completeness, and approvals.
• Maintain master document list and current revisions at points of use.
• Coordinate training records and monitor completion.
• Support supplier quality activities and audits.
• Maintain RMA, CAPA and NCR records and activities.
• Ensure document security and access controls.
• Collaborate with Quality, Engineering, Operations, and Supply Chain.

Skills

Strong attention to detail

Organization

Written and verbal communication

Multi-tasking

ISO 9001 knowledge

ISO 13485 knowledge

GDP understanding

Document change control

Audit support

CAPA/NCR familiarity

RMA handling

Training-record processes

Education

High school diploma or equivalent

ASQ certification or formal document-control training

Associate or Bachelor's degree in Quality, Business Administration, Engineering, or related field

Tools

Microsoft Word

Excel

Outlook

Adobe Acrobat

Document-scanning systems

Job description

Fathom is seeking a Document Control Specialist to maintain an audit-ready records system, manage controlled documents, review DHRs, and coordinate training documents in a regulated manufacturing environment.

You will collaborate with Quality, Engineering, Operations, and Supply Chain to ensure ISO 9001/13485 compliance, change control, and training-record processes while supporting audits.