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Company description:TeDan Surgical Innovations (TSI) designs and manufactures specialty surgical products for use in orthopedic, neuro, thoracic and spine surgeries.Like the look of this opportunity Make sure to apply fast, as a high volume of applications is expected Scroll down to read the complete job description.TSI was founded in 2006 with the goal to innovate and address evolving retraction techniques in spine surgery. We have successfully addressed the need for minimally invasive, posterior, lateral and anterior surgical approaches to the spine, and have introduced access instrumentation for neurological, orthopedic and cardiothoracic procedures. We commit to providing innovative, high-quality surgical access systems designed to optimize exposure and improve the surgeon experience.Job Summary:The Document Control and Records Administrator is a detailed oriented quality focused individual who ensures documentation and record keeping processes conform to ISO 13485 and applicable FDA requirements as well as TSI approved procedures and output documents are accurate. This position is responsible for administering the collection of, authorization, publication, storage, retrieval, and retention documents per established procedures to ensure control and availability of documentation to internal and external stakeholders. This person will interact with all TSI employees to ensure documentation practices are adhered to and fully implemented.Duties/Essential Job Functions: Maintain systems to manage Quality Management System (QMS) documentation (ie. Procedures, Forms, Labeling, Complaint, Supplier Files, CAPA)Manage Excel based logs (Complaints, ECO, & Periodic Review)Ensure data integrity and security of all databases and physical records containing data relevant to product quality and/or Quality Systems processesCoordinate and oversee change control activities; analyze document changes for completeness and alignment with change history. Ensure the correct and timely implementation of document control requests. Verify own work; check format and compliance with document templates.Works with Management, SMEs, and other department heads to ensure training is documented for all applicable employees before documents revisions are releasedAssist with complaint management activities; coordinate complaint investigation with Operations and EngineeringManage and ensure compliance of periodic reviews of controlled documentsKnowledgeable of and follows the applicable provisions of the QA department's standard operating procedures (SOPs) and current Good Manufacturing Practices (cGMPs). Employee remains knowledgeable on an ongoing and timely basis as changes in the SOPs and cGMPs occur.Maintain web based signing platform; onboarding, in-process, and audit reportingScans, files, and maintains all quality records per the record retention policyMaintain confidentiality around sensitive documentationConducting regular reviews and document auditsProvide support during internal and external auditsSupport RAQA Team with projectsOther responsibilities assigned by supervisorExperience/Skills: Strong organizational and analytical skills, with superior attention to detailDemonstrated ability to multitask and prioritize activities to completionSolution-oriented team player that has a customer service approach with internal and external stakeholdersExcellent English written and verbal communicationKnowledge and understanding of standards and regulations: 21 CFR 820, ISO 13485, MDSAP, EU MDRAdvanced knowledge and demonstrated experience with MS Office and Adobe products (e.g., Word, PowerPoint, Excel, Visio, and Acrobat Suite).Knowledge and use of electronic quality management systems (ie. Sharepoint, TrackWise, Qualio, Green Light Guru, Grand Avenue)Direct experience with complaint handing and reportingAbility to foster Teamwork: Pursue trust for each team member. Seek and deliver honest feedback to all team members. Committed and accountable to achieving team goals. Abide by team decisionsRequired Education/Licensing/Certification: Highschool diploma or equivalent; college degree preferredMinimum 2 years' experience in document management, archive management, or records managementMinimum 2 years' experience with medical device complaint and vigilance requirementsPhysical Requirements: On SiteBusiness casual attire.Occasionally requires attending corporate functionsAbility to lift up to 25lbs.IndustryMedical DeviceEmployment TypeFull-time