Job Search Results for medical device regulations

{"JobID":269389,"JobType":["Contract"],"EmployerID":null,"Location":{"Latitude":-71.074586,"Longitude":42.372558,"Distance":null},"State":"Massachusetts","Zip":"02141","ReferenceID":"VMS-PHI-PHHJP00021494","PostedDate":"\/Date(1677456000000)\/","Description":"Document Control and Training Specialist In this role you have the opportunity to Lead global project execution and provide recommendations to management and business category leaders for Hospital Patient Monitoring HPM for projects including but not limited to Legal Manufacturing Consolidation and QMS Simplification. This position will work within a global network to communicate and address challenges related to strategic transformation and consolidation projects while driving standardization and compliance in the Business Group. You are responsible for bull Establishing and providing document control support to authors and process owners in defining and producing lean Quality System documents and records bull Ensuring and providing direction regarding proper quality of the content of documentation and records bull Establishing and managing proper document review processes bull Ensuring availability and publishing of controlled documents bull Establishing monitoring and responding to metrics on the efficacy and efficiency of the document management system and its ability to support the business bull Collecting and maintaining documents and records of the latest revision level bull Timely distribution of latest revision level documents and records to appropriate users and ensuring that obsolete documentation is removed from distribution and publication bull Maintaining the document management system an ensuring fast retrieval of documents and records bull Controlling issuance of document numbers including maintenance of proper document registers bull Ensuring proper document classification sorting filing and archiving in accordance with requirements bull Reviewing correct formatting and completeness of documentation bull Responsible for preparing document transmittals bull Archiving Quality records per process bull Accountable for transformation-related strategic initiatives supporting the PQMS structure bull Ensures the addition and management of any local QMS documents in line with the evolution of the PQMS bull Ensures training and training registration as per the QMS and generates training content for QMS documents as necessary bull Approve each training material prior to usage and control the set and recording of approved trainings bull Ensure that training content is controlled and access to make changes is managed bull Ensure the assignment of training requirements profiles and documentation for all job required training bull Ensure that managers assign the correct training profiles to all individual employees based on job requirement profiles bull Report on training compliance and training related KPIs bull Ensure all mandatory training requirements are set and training is executed as required bull Administer both profiles and training records in line with regulatory requirements bull Ensure Training Management System setup in accordance with transformation of the QMS To succeed in this role you should have the following skills and experience bull Bachelors degree in a scientific or technical field or medical device certifications bull 3 years of experience in the medical device industry or similar work experience bull Strong working knowledge of GMPs and other FDA regulations bull Project Management Skills preferred bull Experience validating application activities. bull Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues. bull Experience in corrective and preventive actions including root cause analysis documenting findings/actions and implementing actions. bull Proven analytical capabilities bull Excellent communication organizational and project management skills bull Successful experience working with cross-functional teams across multiple work locations bull Network oriented and able to interact with different business functions and can work within numerous systems bull Work cooperatively in a team environment **Must be available to work East Coast Hours **Remote position** Experience: 2-5 years of experience in position or specialization. Education: High-school/Associates or equivalent experience if applicable. Certification if applicable. Open sort and route incoming mail answer correspondence and prepare outgoing mail. Complete and mail bills contracts policies invoices and checks. Compile copy sort and file records of office activities. Answer phones direct calls and take messages. Operate office machines photocopiers and scanners facsimile machines voice mail systems and personal computers.","Title":"Document Processor II","City":"Cambridge","ExpirationDate":null,"PriorityOrder":0,"Requirements":null,"Skills":null,"Industry":"Specialist","Country":"US","Division":null,"Office":null,"IsRemoteJob":true,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":51.1900,"SalaryLow":42.1600,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}