Document Control Specialist
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Key details
- Salary
- $46K–$62K/yr
- Location
- Brimfield, MA, United States
- Work style
- Onsite
- Level
- Mid level
- Experience
- 3–6 yrs
- Function
- Operations & Strategy
- Focus area
- other
- Posted
- 3d ago
Skills
auditingcapachange controldocument controldocument managementerpexcelinternal auditiso 13485microsoft accessmicrosoft wordoutlookquality management systems
About the role
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 are 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:
Document Management:
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.
Apply today and help us bring life-changing medical technologies to patients worldwide.
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 are 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:
Document Management:
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.
Apply today and help us bring life-changing medical technologies to patients worldwide.