Document Control Specialist

Document Control SpecialistAt 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 dayGenerous paid time off benefits and 10 paid HolidaysGrowth Opportunities401K plan with company matchEarn additional ($800 a year) for Monthly Attendance BonusOn-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 ReviewMaintenance of the document control database, dailyProcessing, Routing and tracking of documents for approval, dailyRelease of documents and notification, after approvalsEnsure current document revisions are available, dailySupport maintenance of electronic Training Requirements fileIdentification of obsolete documents and removal for filingSupplier Notification maintenanceSupport maintenance of CAPA LogAttend CAPA meetings as neededProcess Change Requests (CRF's)Support maintenance of CRF logDistribute Change Request Forms (CRF's) via emailScan/ File Device Master Records (DMR's)File PWO Files and maintain Log, as neededParticipate in continuous improvement activities

Control of Quality Records:

Ensure adequate long-term storage of quality records to prevent damage, deterioration and loss, as neededTimely retrieval of documents placed on long-term storage, as neededControl and disposition of quality recordsQuality record legibility and maintenancePersonnel Training:Compilation of new employee orientation and training documentsSupport maintenance of New Hire Training records

Audits:

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

Job Requirements:

High school diploma with 3+ years of applicable experienceMinimum 2 years' experience in quality management systems preferably within the medical device industry including interaction with regulatory agenciesUnderstanding of US and International Medical Device Regulations including but not limited to 21 CFR 820 and ISO 13485Knowledge 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 systemsStrong communication skills, both written and oral; Ability to lead meetings and presentationsMust be able to effectively communicate up/down and across different levels of the organizationAbility to independently troubleshoot issues with electronic systemsExperience in training users on systems and processes within an electronic environmentDocument review and procedural writing experience is preferredAuditing experience requiredProficient in computer applications such as Microsoft Word, Excel, Access and OutlookUnderstanding of office procedures, including filing, record management and archiving documentationProactive, demonstrate initiative and self-motivatedStrong communication and organizational skillsDetail orientedAbout 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.