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

The Document Control Specialist administers and maintains the organization's controlled-document and quality-record systems to ensure document integrity, availability, security, traceability, and effective lifecycle control. The position coordinates the creation, review, approval, issuance, revision, distribution, retrieval, retention, and archival of controlled documents and records.

The role serves as a primary administrator for MasterControl, coordinates the scanning and indexing of Device History Records (DHRs), supports engineering change-control activities within applicable ERP and product data management systems, and provides document-control training and guidance to employees.

The position works cross-functionally with Quality, Regulatory Affairs, Engineering, Operations, and other departments to maintain compliance with company procedures and applicable requirements, including ISO 13485:2016, the FDA Quality Management System Regulation (QMSR) under 21 CFR Part 820, EU MDR, TPED/TPER, and other applicable requirements.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Administer the controlled-document lifecycle, including initiation, review, approval, issuance, distribution, revision, obsolescence, archival, retrieval, and retention.
• Ensure controlled documents are appropriately identified, approved, current, accessible, legible, traceable, and protected from unintended use or alteration.
• Coordinate the issuance, distribution, retrieval, and removal of obsolete controlled documents in accordance with established procedures.
• Maintain document and record metadata, classifications, effective dates, revision history, retention requirements, and associated audit trails.
• Coordinate the scanning, indexing, review, and archival of DHRs and other designated quality records.
• Monitor scanning activities to ensure records are complete, legible, accurately indexed, and retrievable before transfer to the approved electronic repository.
• Conduct periodic controlled-document retrieval, reconciliation, or recall exercises to verify document availability, traceability, distribution control, and removal of obsolete versions.
• Serve as a primary administrator for MasterControl, including user account administration, role and permission support, workflow maintenance, training assignments, and approval-task administration.
• Support onboarding and offboarding activities associated with MasterControl access and assigned system responsibilities.
• Coordinate document and training workflows and provide routine system access, routing, and workflow support.
• Support and coordinate validation activities and continued maintenance of the validated state of MasterControl in accordance with approved validation, change-control, and applicable computer software assurance procedures.
• Generate MasterControl reports and data to support quality-system monitoring, management review, training compliance, and established departmental metrics.
• Provide document-control and applicable system orientation to newly hired employees.
• Train and guide employees on document-control requirements, good documentation practices, MasterControl use, and applicable procedures.
• Provide ongoing support to document owners, authors, reviewers, approvers, and other system users.
• Promote consistent application of document-control and records-management requirements across the organization.
• Compile, maintain, and report assigned document-control and quality-system metrics in accordance with established reporting requirements.
• Monitor applicable indicators such as workflow timeliness, overdue approvals, overdue training, record-scanning backlog, document-retrieval or recall results, and other assigned measures.
• Facilitate or participate in scheduled quality metric review meetings, as assigned.
• Identify document-control trends, recurring issues, and opportunities for process improvement.
• Recommend and support improvements intended to increase the effectiveness, efficiency, accuracy, and compliance of document-control and records-management processes.
• Support internal, external, regulatory, customer, certification, and notified-body audits by retrieving and organizing controlled documents, records, and applicable objective evidence.
• Participate as an internal auditor and serve as an audit lead when qualified and assigned.
• Ensure requested documentation is accurate, appropriately controlled, and readily retrievable during audit activities.
• Document and elevate identified document-control or records-management discrepancies through applicable quality-system processes.
• Retrieve and compile approved historical complaint, service, or postmarket records in support of authorized investigations, trending activities, and data requests.
• Process approved Engineering Change Orders (ECOs) and associated documentation within applicable ERP or product data management systems.
• Coordinate document-control activities associated with approved engineering and quality-system changes.
• Verify that affected controlled documents, records, training assignments, and applicable implementation activities are appropriately routed and completed before change closure, as required by established procedures.
• Maintain traceability between approved changes and affected controlled documentation.
• Maintain document archives and support timely retrieval of records in accordance with established retention requirements.
• Provide functional guidance and work coordination to personnel performing document-control or records-scanning activities.
• Support Quality Management System activities and improvement initiatives as assigned.
• Perform other duties as assigned.

Competencies / Success Factors

• Detail Orientation / Quality Focus
• Time Management
• Clerical / Technology Skills
• Analytical Skills
• Problem-Solving
• Interpersonal Communication
• Team Orientation
• Coaching / Developing Others
• Change Management
• Adaptability / Flexibility

Supervisory Responsibility

This position has no direct supervisory responsibility. The Document Control Specialist may provide functional direction, training, work coordination, and technical guidance to employees performing document-control, records-management, or scanning activities. The position may also serve as a functional lead for assigned document-control activities, projects, or system initiatives.

This position primarily operates in a professional office environment and routinely uses computers, electronic document-management systems, ERP systems, scanners, photocopiers, telephones, filing systems, and other standard office equipment.

The position may periodically perform activities in manufacturing, warehouse, records-storage, or other operational areas as necessary to support document and records-management responsibilities.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Frequent standing, sitting, walking, bending, stooping, twisting and occasional crawling.
• Occasional lifting up to 50 lbs., occasional heavier lifting.
• Occasional pushing, pulling and handling of materials.

Travel

Occasional travel may be required to support document-control activities, audits, training, or activities at other company locations.

Required Education and Experience

• Bachelors degree in Quality, Business Administration, Information Management, Engineering Technology, or a related discipline, or equivalent relevant work experience.
• Minimum of three years of experience in document control, records management, quality systems, or a related function.
• Minimum of one year of experience in the medical-device, pharmaceutical, biotechnology, or another regulated manufacturing industry.
• Working knowledge of controlled-document lifecycle and quality-record management practices.
• Experience using an electronic document-management or quality-management system.
• Proficiency with Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint.
• Ability to manage multiple document workflows, assignments, and competing priorities.

Preferred Education and Experience

• Masters degree in Quality, Business Administration, Information Management, Engineering Technology, or a related discipline, or equivalent relevant work experience.
• Five or more years of document-control, records-management, or Quality Management System experience within the medical-device industry.
• Experience administering MasterControl or a comparable electronic Quality Management System.
• Experience with ERP or product data management systems.
• Working knowledge of ISO 13485:2016, FDA QMSR under 21 CFR Part 820, EU MDR, and other applicable medical-device regulatory requirements.
• Experience supporting regulatory, certification, customer, or notified-body audits.
• Experience supporting validated computerized systems and associated change-control activities.
• ASQ or Notified Body certification as an Internal Auditor or Lead Auditor related to ISO 13485, ISO 9001, ISO 19011, or another applicable Quality Management System standard.
• Experience training or providing functional leadership to document-control or quality-system personnel.

Additional Eligibility Qualifications

None required for this position.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

CAIRE is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.