EQMS Document Control & Training Lead

Theragenics; Buford (GA); On-site; USD 52,000 - 72,000; Full time

Benefits offered by this job

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Job summary

Theragenics is seeking a Document Control Training Coordinator to manage EQMS documentation and change control. This role coordinates the Document Control department and training functions to align with medical device regulations, ensuring proper archiving, retrieval, and revision history.

Responsibilities include issuing ECNs, maintaining current document versions, conducting monthly audits, and providing EQMS user training at all levels.

Qualifications

• Detail oriented, accuracy and consistency are essential.
• Strong organizational, communication and customer service abilities.
• Ability to multitask and work independently in a fast-paced setting.
• Familiarity with ISO 13485 and cGMP compliance.

Responsibilities

• Coordinate changes to controlled documents and their release/distribution.
• Process ECNs in line with regulatory and company requirements.
• Maintain revision history and archive prior revisions.
• Ensure access to current document versions.
• Conduct monthly audits of manufacturing/quality areas for document status.
• Manage Quality Logs and periodic reviews of open items.
• Notify appropriate personnel for timely reviews (3-year cycle).
• Coordinate archival, storage, and destruction per retention policy.
• File and retrieve active quality records in Document Control.
• Provide back-room audit support during FDA/Corporate inspections.
• Train all employees and maintain EQMS curricula; deliver user training.

Skills

Detail oriented

Organization skills

Communication skills

Customer service skills

Multitasking

Independence

Problem solving

Ability to follow instructions

Education

High School Diploma

Associate degree or higher

Tools

Microsoft Word

Microsoft Excel

Job description

Theragenics is seeking a Document Control Training Coordinator to manage EQMS documentation and change control. This role coordinates the Document Control department and training functions to align with medical device regulations, ensuring proper archiving, retrieval, and revision history.

Responsibilities include issuing ECNs, maintaining current document versions, conducting monthly audits, and providing EQMS user training at all levels.