Quality Document Control Specialist

Fathommfg; Round Rock, Northern (TX, KY); Hybrid; USD 33,000 - 41,000; Full time

Benefits offered by this job

Health benefits

Paid time off

401k plan

Employee discounts

Job summary

Fathom is seeking a Quality Document Control Specialist in Round Rock, TX to maintain an audit-ready document-control system, review DHRs, and support change control, CAPAs, NCRs, and training records within ISO 9001 and ISO 13485.

Collaborating with Quality, Engineering, Operations, and Supply Chain, you will manage document revisions, ensure traceability, control external documents, and prepare records for internal and customer audits.

Qualifications

• High school diploma or equivalent; associate or bachelor’s in Quality, Business Administration, Engineering, or related field preferred.
• 3–5 years 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 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• Prevent the unintended use of obsolete or superseded documents.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 Return Material Authorization (RMA) records.
• Support CAPA and 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 GDP.
• 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.

Skills

Document control

Quality systems

GDP knowledge

ISO familiarity

Education

High school diploma

Assoc./Bach. in Quality/Engineering

Tools

Microsoft Word

Microsoft Excel

Adobe Acrobat

Document scanning systems

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Quality Document Control Specialist

FullTime Technical Round Rock, TX, US

7 days ago Requisition ID: 2659

$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.

Qualifications/Requirements:

• High school diploma or equivalent required; associate or bachelor’s degree in Quality, Business Administration, Engineering, or a related field preferred.
• 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.
• ASQ certification or formal document-control and quality-system training preferred.

What we offer

Health Benefits: Medical, dental, and vision coverage. Company paid for Life insurance, short-term and long-term disability insurance.

Additional Benefits: Paid time off, Floating Holidays, Volunteer time off, and sick time off (depending on state of employment). 401k Plan

Employee Perks: Discounts on products and services.

Equal Opportunity Employer/Veterans/Disabled

This employer participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, this employer is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue before the employer can take any action against you, including terminating your employment. Employers can only use E-Verify once you have accepted a job offer and completed the Form I-9.