Quality Document Control Specialist - Medical Devices

Viant Medical Inc.; Massachusetts; On-site; USD 30,000 - 41,000; Full time

Job summary

Viant Medical Inc. is seeking a Document Control Specialist to support quality documentation and regulatory compliance.

You will maintain the document control database, process change requests, and ensure up-to-date document revisions across the organization in a regulated medical device environment. The role requires experience with electronic systems, quality management, and CAPA processes, with emphasis on ensuring accuracy in records and training documentation.

Qualifications

• 3+ years of applicable experience in quality management systems
• Experience with quality management systems and document control
• Understanding of US medical device regulations (21 CFR 820) and ISO 13485
• Experience administering electronic systems (ERPs) and training records management

Responsibilities

• Maintain the document control database daily
• Process, route, and track documents for approval daily
• Release documents after approvals
• Ensure current document revisions are available daily
• Support maintenance of electronic Training Requirements file
• Identify obsolete documents and remove for filing
• Maintain supplier notification records
• Support CAPA log maintenance and attend CAPA meetings
• Process Change Requests (CRFs) and log maintenance
• Distribute CRFs via email
• Scan/file Device Master Records (DMRs)
• File PWO files and maintain logs
• Participate in continuous improvement activities
• Audit support for external and internal audits

Skills

Quality systems

Document control

Auditing

ERP systems

Training records

Education

High school diploma

Tools

MS Word

Excel

Access

Outlook

Job description

Viant Medical Inc. is seeking a Document Control Specialist to support quality documentation and regulatory compliance.

You will maintain the document control database, process change requests, and ensure up-to-date document revisions across the organization in a regulated medical device environment. The role requires experience with electronic systems, quality management, and CAPA processes, with emphasis on ensuring accuracy in records and training documentation.