Document Control Specialist

Viant Medical; Brimfield (MA); On-site; USD 30,000 - 41,000; Full time

Job summary

Viant Medical Inc. Brimfield is seeking a QA Document Control professional to maintain the electronic document system, support CAPA/log activities, and assist in internal and external audits within a regulated medical device environment.

You will ensure current revisions, manage records, and support training and continuous improvement initiatives across the organization.

Qualifications

• Minimum 3+ years in quality assurance or quality management systems.
• Experience with medical device regulations (21 CFR 820, ISO 13485) preferred.
• Proficient in document control processes and records management.
• Experience auditing internal and external processes.
• Strong communication and training abilities.

Responsibilities

• Maintain document control database and ensure current revisions.
• Process, route, and track documents for approval daily.
• Release documents after approvals and notify relevant parties.
• Support CAPA and CRF log maintenance.
• Contribute to continuous improvement activities.
• Assist in audits and prepare records.

Skills

Quality management systems

Document control

Audits

Microsoft Office

Education

High School Diploma with 3+ years experience

Tools

ERP systems

Job description

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!

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.

Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.