Document Control Specialist

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

Document Control Specialist

At Viant, the work you do directly supports the quality and compliance of life-changing medical devices, helping ensure products meet the highest standards for safety and performance. As a member of our Quality Assurance team, you will play a critical role in maintaining documentation systems and processes that support regulatory compliance, operational excellence, and patient outcomes. We are committed to helping employees grow their careers through meaningful work, professional development, and opportunities to expand their impact across the organization. Guided by our promise, We're In It For Life., we invest in our people, their success, and the important work they do every day.

New employees eligible for the following benefits effective date of hire!

• Full Medical, Dental & Vision, effective on your 1st day
• Generous paid time off benefits and 10 paid Holidays
• Growth Opportunities
• 401K plan with company match
• Earn additional ($800 a year) for Monthly Attendance Bonus
• On-Demand Pay: Access your pay as soon as you have earned it!

We offer market competitive compensation. Potential salary range for this role is $22.00-$30.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Job Responsibilities:

• DHR Review
• Maintenance of the document control database, daily
• Processing, Routing and tracking of documents for approval, daily
• Release of documents and notification, after approvals
• Ensure current document revisions are available, daily
• Support maintenance of electronic Training Requirements file
• Identification of obsolete documents and removal for filing
• Supplier Notification maintenance
• Support maintenance of CAPA Log
• Attend CAPA meetings as needed
• Process Change Requests (CRF’s)
• Support maintenance of CRF log
• Distribute Change Request Forms (CRF’s) via email
• Scan/ File Device Master Records (DMR’s)
• File PWO Files and maintain Log, as needed
• Participate in continuous improvement activities

Control of Quality Records:

• Ensure adequate long-term storage of quality records to prevent damage, deterioration and loss, as needed
• Timely retrieval of documents placed on long-term storage, as needed
• Control and disposition of quality records
• Quality record legibility and maintenance
• Personnel Training:
• Compilation of new employee orientation and training documents
• Support maintenance of New Hire Training records

Audits:

• External Audits:
• Participate in External Audits as backroom support
• Internal Audits:
• Member of the audit team, perform assigned internal audit

Job Requirements:

• High school diploma with 3+ years of applicable experience
• Minimum 2 years' experience in quality management systems preferably within the medical device industry including interaction with regulatory agencies
• Understanding of US and International Medical Device Regulations including but not limited to 21 CFR 820 and ISO 13485
• Knowledge of Quality Systems programs including but not limited to Document Control, Record Control, Change Control, Training, and Device Master Record (DMR)
• Demonstrated experience in administration of electronic systems such as ERP systems
• Strong communication skills, both written and oral; Ability to lead meetings and presentations
• Must be able to effectively communicate up/down and across different levels of the organization
• Ability to independently troubleshoot issues with electronic systems
• Experience in training users on systems and processes within an electronic environment
• Document review and procedural writing experience is preferred
• Auditing experience required
• Proficient in computer applications such as Microsoft Word, Excel, Access and Outlook
• Understanding of office procedures, including filing, record management and archiving documentation
• Proactive, demonstrate initiative and self-motivated
• Strong communication and organizational skills
• Detail oriented
• About the site:

Our Brimfield facility specializes in medical device assembly, finishing, and packaging, supporting high-quality, scalable production within a regulated environment.

Viant is a global medical device partner providing design, development, manufacturing, and assembly services through capabilities in materials, plastics, metals, extrusion, and automation. With nearly 6,000 employees across 24 locations worldwide, it delivers high-quality, life-enhancing products with the scale and expertise to bring devices to market efficiently. Learn more at Viant Medical’s website or in LinkedIn.