Document Control Specialist

Cutera-Inc; Raleigh (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

Cutera-Inc in Raleigh, NC is seeking a Document Control Specialist to administer and improve our document control and training management systems, ensuring compliance with FDA QSR, ISO 13485, EU MDR, and 21 CFR Part 11.

You will manage document lifecycles, support audits, and provide user training on Arena PLM and related tools, collaborating with cross-functional teams in a fast-paced regulated environment.

Qualifications

• 2-5 years of experience in document control or a regulated industry.
• Experience with controlled documentation and electronic document management systems.
• Familiarity with FDA Quality System requirements and ISO 13485; EU MDR and 21 CFR Part 11 preferred.
• Arena PLM experience is preferred.
• Proficiency in Microsoft Word, Excel, and PowerPoint.

Responsibilities

• Administer and maintain document control and training management systems (Arena PLM).
• Manage document lifecycle from submission to archival including revisions and approvals.
• Maintain document master lists, revision histories, and controlled records (DHF/DMR/DHR).
• Support Change Management and ensure only current, approved docs are used.
• Maintain training matrices and assist with training assignments.
• Provide user support and training on document management systems and electronic signatures.
• Generate reports and monitor key metrics for audits and regulatory inspections.
• Support regulatory filing activities and internal QA activities.

Skills

Document control

Quality assurance

Attention to detail

Time management

Written communication

Verbal communication

Organization

Cross-functional collaboration

Education

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

Tools

Arena PLM

ERP

eDMS

Microsoft Office

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.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.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.