QMS Specialist

[Applicants: Be among the first 25 applicants | Industry: IT Services and IT Consulting | Type: Full-time | Level: Mid-Senior level] Role descriptionPosition SummaryThis position will support quality activities and projects to successfully meet department and corporate goals This position will require a mastery of understanding interpreting and implementing FDA and international regulations and using the guidance to create and maintain department procedures Key contributor in authoring and leading the development life cycle of a project Support and collaboration for one or more areas of business support software and IT compliance including but not limited toMaintaining the Quality Management System FDA and International Regulation and StandardsProviding expert guidance to teams working within an FDAregulated environmentMapping and creating diagrams for enterprise systemsCreating system and functional risk assessments requirement documentation validation plans and reportsSupporting software development project teamsContinuous ImprovementAdditional quality responsibilities as assignedHave a mastery level understanding of the Software Development Life Cycle SDLCDuties and ResponsibilitiesMaintain the Quality Management System and evaluate software and business processes to comply with existing and new FDA and International regulationsAbility to lead a projects software development lifecycle as the Quality LeadAuthor documentation and provide guidance throughout the entire Software Development Life Cycle GxP Part 11 Requirements Validation and Summary documentationProvide mastery guidance on the proper use of wording for a requirement and provide test guidance on its testabilityHave the ability to understand large enterprise systems and experience working as a Quality Engineer with large enterprise software systems such as SAP Cloud PLM Oracle Camstar etcCommunicate with teams and provide quality guidance on a project teamBe able to learn technical jargon quickly and communicate with software engineers and ITCommunicate to small teams peers and managementProvides guidance and support with Quality solutions affecting and defining the Quality Management SystemSupports new regulation gap analysis and updates to the Quality Management SystemSupport IT enterprise systems infrastructure complex IT systems implementation deployment postimprovements and maintenanceEnsure compliance with Domestic and International quality management systemsSupports continuous impro...