Senior Document Control Specialist

Under minimal supervision, this role is actively responsible for supporting the corporate documentation control system at a senior level of experience within defined company policies, procedures, and regulatory requirements. This includes creating, editing and maintaining the manufacturing and quality system documentation.ESSENTIAL FUNCTIONS:Change ControlWork with Quality Assurance Management and other departments in the generation, modification and processing of document changes within defined procedures, including changes associated with company projects such as new products, equipment and componentsMonitor the quality of new and revised documents for accuracy, clarity and compliance to internal and external standardsSupports the cross-functional review and approval of document changes, including facilitating discussion, resolving change packet issues, and ensuring high quality review and participation by all membersUnderstand how change affects Bill of Materials (BOMs) and provide input as applicable in the change control processImplement changes into Electronic Data Management System (i.e., Master Control and / or ERP systems)Coordinates the review and prioritization in the processing of change packets to ensure timely processing while maintaining high quality standardsRecommend and implement changes or improvements to change control processParticipate in product launch core teams by attending meetings, creating and maintaining QA deliverables such as Design Trees, X-revisions/Pre-Production, BOMs, and launch status updatesProvide training, as required, on change control processes (e.g. change control, pre-production (X-Rev), etc.). Training may include inter/intra department class room / one-on-one training.Work with QA Management to develop metrics in the change packet process for the purposes of monitoring performance and reporting to departmental managementFile Maintenance and AuditingFacilitate Quality Records archiving (scanning), where appropriate: including: manufacturing Device History Records (DHRs), Change Packets, Design History Files, Validations, Complaints and ReceiversMaintain and audit document, change control and other QA department files, as well as associated electronic logs and databases per GMPs, Federal Regulations, International Standards, and company proceduresProvide Corrective/Preventive Action Request responses and perform their associated follow up activities as it relates to document control Administration - daily work scheduling/planningGenerate status reports and / or Management Operations Review reportsParticipate with the Department Manager group in the planning of department goals and objectives in meeting the corporate strategic mission and contributing to the achievement of these goalsRepresent the department in internal and external audit activities and other departmental meetings as requiredEducation/ExperienceHigh school diploma or equivalent required. Bachelor degree in Business Administration, Management, or Management Science or equivalent work experience highly preferred.5 years' experience in documentation control systems required, with preference in coordination and administration of systems within a Medical Device Single Audit Program (MDSAP)/ISO and high-volume manufacturing work environmentDemonstrated abilities and knowledge in document change management required Knowledge/SkillsAdvanced English skills: writing, grammar, proofreading, redliningAdvanced computer skills: data entry/typing, Word, Excel, Access, other Office softwareTechnical experience and knowledge in developing and coordinating documentation systemsFull understanding of documentation control systems within a medical device or ISO, and high-volume manufacturing environmentEffective verbal communication skills