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. 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.