Document Control & Training Systems Lead

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

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.