Quality Records & Compliance 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• Prevent the unintended use of obsolete or superseded documents.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

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.