Quality Document Control Specialist

Fathom Mfg • Round Rock, TX

2d

About The Position

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.

Requirements

• High school diploma or equivalent required
• 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 Good Documentation Practices (GDP) and quality-record retention requirements.
• Proficiency with Microsoft Word, Excel, Outlook, Adobe Acrobat, and document-scanning systems.
• Ability to interpret procedures, specifications, drawings, forms, and customer requirements.
• Strong attention to detail, accuracy, organization, and record traceability.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities, deadlines, and document requests with minimal supervision.
• Ability to work effectively with Quality, Engineering, Operations, Supply Chain, and management.
• Ability to maintain confidential and sensitive company, employee, supplier, and customer information.

Nice To Haves

• Associate or bachelor’s degree in Quality, Business Administration, Engineering, or a related field preferred.
• ASQ certification or formal document-control and quality-system training preferred.

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.

Benefits

• Medical, dental, and vision coverage.
• Company paid for Life insurance, short-term and long-term disability insurance.
• Paid time off, Floating Holidays, Volunteer time off, and sick time off (depending on state of employment).
• 401k Plan
• Discounts on products and services.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED