Document Control Specialist

Cutera, Inc.; Raleigh (NC); On-site; USD 65,000 - 75,000; Full time

Job summary

Cutera, Inc. seeks a Document Control Specialist to oversee the organization, maintenance, and control of company documentation ensuring accuracy, accessibility and regulatory compliance.

The role administers document control and training management processes, coordinates changes and approvals, and partners with cross-functional teams to keep a compliant documentation system. Responsibilities include managing document lifecycles, training records, and reports; supporting audits and regulatory

Qualifications

• Associate’s or Bachelor's degree in a technical, business, quality, or related field preferred.
• 2–5 years in document control, quality assurance, or a related regulated function.
• Experience with controlled documentation, quality records, and electronic document management systems.
• Familiarity with FDA QSR/ISO 13485; knowledge of EU MDR and 21 CFR Part 11 preferred.
• Proficiency with Arena PLM or similar systems and Microsoft Office.

Responsibilities

• Administer and maintain document control and training management systems, including Arena PLM.
• Manage the document lifecycle: submission, routing, review, approval, publishing, revision, and archival.
• Maintain document master lists, revision histories, templates, and controlled records (DHF/DMR/DHR).
• Support Change Management by verifying document changes and filing approvals.
• Ensure obsolete documents are removed and current, approved docs are available.
• Maintain training matrices, plans, and records; monitor training completion.
• Provide user support and training on document management systems and electronic signatures.
• Coordinate periodic document reviews with owners to ensure timely completion.
• Generate document control and training reports; track key metrics.
• Support audits, regulatory inspections, and audit prep with requisite documentation.

Skills

Attention to detail

Documentation management

Cross-functional collaboration

MS Office proficiency

Regulatory compliance

Quality system knowledge

Education

Associate’s or Bachelor’s degree in technical, business, quality, or related field

Tools

Arena PLM

eDMS / PLM tools

ERP systems

Job description

Position Summary

The Document Control Specialist supports the organization, maintenance, and control of company documentation to ensure accuracy, accessibility, and compliance with applicable regulatory requirements. This role administers document control and training management processes, supports document changes and approvals, and collaborates with cross-functional teams to maintain an effective and compliant documentation system.

Position Summary

The Document Control Specialist supports the organization, maintenance, and control of company documentation to ensure accuracy, accessibility, and compliance with applicable regulatory requirements. This role administers document control and training management processes, supports document changes and approvals, and collaborates with cross-functional teams to maintain an effective and compliant documentation system.

Duties & Responsibilities

• Administer and maintain document control and training management systems, including Arena PLM.
• Manage the document lifecycle, including submission, routing, review, approval, publishing, revision, and archival of controlled documents.
• Maintain document master lists, revision histories, templates, and controlled records, including DHF, DMR, DHR, and other quality documentation.
• Support Change Management activities by verifying document changes and ensuring approved documentation is properly processed and filed.
• Ensure obsolete and superseded documents are removed from circulation and that only current, approved documents are available for use.
• Maintain training matrices, plans, and records; support training assignments and monitor completion.
• Provide user support and training on document management systems, electronic signatures, and document control processes.
• Support periodic document reviews and coordinate with document owners to ensure timely completion.
• Generate Document Control and training reports and track key metrics.
• Support internal and external audits, regulatory inspections, and audit preparation by providing required documentation and records.
• Support Quality System Software activities, including validation activities, as requested.
• Maintain external reference standards and support regulatory filing activities.
• Identify opportunities to improve document control processes, system usability, and compliance.
• Other duties as assigned or required.

Qualifications

Minimum Requirements & Qualifications:

• Associate’s or Bachelor’s degree in a technical, business, quality, or related field preferred.
• 2-5 years of experience in document control, quality assurance, or a related function within a regulated industry.
• Experience with controlled documentation, quality records, and electronic document management systems.
• Working knowledge of document control processes, including document revisions, change control, approval workflows, and archival requirements.
• Familiarity with FDA Quality System requirements and ISO 13485; knowledge of EU MDR and 21 CFR Part 11 preferred.
• Experience with PLM, ERP, eDMS, or other document management systems; Arena PLM experience preferred.
• Proficiency in Microsoft Office, particularly Word, Excel, and PowerPoint.
• Strong attention to detail, organization, and time-management skills.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities and work effectively both independently and as part of a cross-functional team.
• Ability to work effectively in a fast-paced, regulated environment.