Document Control Specialist

Viant • Brimfield, MA

5d

About The Position

As a member of Viant’s Quality Assurance team, the Document Control Specialist supports the quality and compliance of medical devices by maintaining documentation systems and processes that enable regulatory compliance, operational excellence, and patient outcomes. The role supports document management, quality records, personnel training records, and audit activities at Viant’s Brimfield facility, which specializes in medical device assembly, finishing, and packaging.

Requirements

• High school diploma and at least 3 years of applicable experience.
• At least 2 years of experience in quality management systems, preferably in the medical device industry, including interaction with regulatory agencies.
• Understanding of US and international medical device regulations, including 21 CFR 820 and ISO 13485.
• Knowledge of quality systems programs, including document control, record control, change control, training, and Device Master Records (DMRs).
• Demonstrated experience administering electronic systems such as ERP systems.
• Strong written and oral communication skills, including the ability to lead meetings and presentations.
• Ability to communicate effectively across different organizational levels.
• Ability to independently troubleshoot issues with electronic systems.
• Experience training users on systems and processes in an electronic environment.
• Auditing experience.
• Proficiency in Microsoft Word, Excel, Access, and Outlook.
• Understanding of office procedures, including filing, record management, and document archiving.
• Proactive, self-motivated, and able to demonstrate initiative.
• Strong organizational skills and attention to detail.

Nice To Haves

• Document review and procedural writing experience.

Responsibilities

• Maintain the document control database.
• Process, route, and track documents for approval.
• Release documents and notify relevant parties after approval.
• Ensure current document revisions are available.
• Support maintenance of the electronic Training Requirements file.
• Identify obsolete documents and remove them for filing.
• Maintain supplier notifications.
• Support maintenance of the CAPA log and attend CAPA meetings as needed.
• Support maintenance of the Change Request Form (CRF) log and distribute CRFs by email.
• Scan and file Device Master Records (DMRs).
• File PWO files and maintain the related log as needed.
• Participate in continuous improvement activities.
• Ensure quality records are stored long-term in a way that prevents damage, deterioration, and loss.
• Retrieve documents from long-term storage in a timely manner as needed.
• Control and disposition quality records, ensuring their legibility and maintenance.
• Compile new employee orientation and training documents and support maintenance of new-hire training records.
• Participate in external audits as backroom support.
• Serve on the internal audit team and perform assigned internal audits.

Benefits

• Full medical, dental, and vision coverage effective on the first day of employment.
• Paid time off.
• 10 paid holidays.
• Growth opportunities.
• 401(k) plan with company match.
• Monthly attendance bonus of up to $800 per year.
• On-demand pay access.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED