Document Control Specialist

Viant • Brimfield, MA

7d • $22 - $30 • Onsite

About The Position

At Viant, the Document Control Specialist supports the quality and compliance of medical devices as a member of the Quality Assurance team. The role maintains documentation systems and processes that support regulatory compliance, operational excellence, and patient outcomes. The position is based at Viant’s Brimfield facility, which specializes in medical device assembly, finishing, and packaging in a regulated environment.

The role manages document workflows and quality records, supports personnel training documentation, and participates in internal and external audits. It also supports continuous improvement activities and works with electronic systems and records. Viant describes the position as offering opportunities for professional development and career growth.

Requirements

• High school diploma and 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 U.S. 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 with different levels of the organization.
• Ability to independently troubleshoot issues with electronic systems.
• Experience training users on systems and processes in an electronic environment.
• Auditing experience.
• Proficiency with Microsoft Word, Excel, Access, and Outlook.
• Understanding of office procedures, including filing, record management, and archiving documentation.
• Proactive, self-motivated, and able to demonstrate initiative.
• Strong communication and organizational skills.
• Detail-oriented.

Nice To Haves

• Document review experience.
• Procedural writing experience.

Responsibilities

• Review DHRs.
• Maintain the document control database daily.
• Process, route, and track documents for approval daily.
• Release documents and provide notification after approvals.
• Ensure current document revisions are available daily.
• 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.
• Process Change Request Forms (CRFs), support maintenance of the CRF log, and distribute CRFs by email.
• Scan and file Device Master Records (DMRs).
• File PWO files and maintain the log as needed.
• Participate in continuous improvement activities.
• Ensure adequate long-term storage of quality records to prevent damage, deterioration, and loss.
• Retrieve documents from long-term storage in a timely manner as needed.
• Control and disposition quality records and ensure their legibility and maintenance.
• Compile new employee orientation and training documents.
• Support maintenance of new-hire training records.
• Participate in external audits as backroom support.
• Serve as a member of the 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 to earned wages.

What This Job Offers

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