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 Were In It For Life. we invest in our people their success and the important work they do every 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 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 Log Attend CAPA meetings as neededProcess Change Requests (CRFs)Support maintenance of CRF log Distribute Change Request Forms (CRFs) via emailScan/ File Device Master Records (DMRs)File PWO Files and maintain Log as neededParticipate in continuous improvement activitiesControl 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 recordsAudits: External Audits:Participate in External Audits as backroom supportInternal Audits:Member of the audit team perform assigned internal auditJob 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 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 is a global medical device partner providing design development manufacturing and assembly services through capabilities in materials plastics metals extrusion and automation. With nearly 6000 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 atViant Medicals website or in today and help us bring life-changing medical technologies to patients worldwide.