MasterControl Document Control Specialist

CAIRE Inc.; Ball Ground (GA); On-site; USD 60,000 - 90,000; Full time

Job summary

CAIRE Inc. is seeking a Document Control Specialist to administer the controlled-document lifecycle, maintain quality records, and ensure traceability and compliance with ISO 13485:2016 and FDA QMSR requirements.

The role focuses on MasterControl administration, DHR scanning/indexing, and collaboration with Quality, Regulatory Affairs, Engineering, and Operations to sustain audit-ready documentation and effective change control across ERP and product data systems.

Qualifications

• Bachelor's degree or higher in a relevant field and related work experience.
• Experience with document-control, records management, or quality systems in regulated manufacturing is required.
• Experience with electronic document-management systems and MS Office.

Responsibilities

• Administer controlled-document lifecycle including initiation, review, approval, and archival.
• Maintain document metadata, revision history, and audit trails.
• Coordinate scanning/indexing of quality records and DHRs.
• Serve as MasterControl administrator and user support.

Skills

Document control

Quality systems

Regulatory compliance

Auditing

Cross-functional collaboration

Training

Education

Bachelor's degree in Quality/Management/Engineering or related

Master's degree preferred

Tools

MasterControl

ERP systems

Quality Management System software

Job description

CAIRE Inc. is seeking a Document Control Specialist to administer the controlled-document lifecycle, maintain quality records, and ensure traceability and compliance with ISO 13485:2016 and FDA QMSR requirements.

The role focuses on MasterControl administration, DHR scanning/indexing, and collaboration with Quality, Regulatory Affairs, Engineering, and Operations to sustain audit-ready documentation and effective change control across ERP and product data systems.