Quality Systems Documentation Specialist - REMOTE

We are hiring Quality Systems Documentation Specialist - REMOTE.Please let me know if you are interested or anyone who might be interested.Client: Major Medical Device ClientPosition: Quality Systems Documentation Specialist - REMOTEDuration: 12+ months on W2Location: REMOTE or Onsite in Cary, IL 60013Pay Rate: $40.00-$45.00/ Hr on W2___________________________________________________________________________________________Job DescriptionSummaryThe contractor in this role will support the update and alignment of Quality Management System (QMS) documentation to reflect the functionality and processes of a new Product Lifecycle Management (PLM) system.They will collaborate closely with the project manager and cross-functional teams to ensure that documentation and training materials align with updated process flows introduced through the PLM implementation.In addition, the contractor may assist with User Acceptance Testing (UAT) and contribute to the development of training content to promote successful adoption of the new system.Essential Duties & ResponsibilitiesQMS Documentation UpdatesReview existing QMS documentation (procedures, work instructions, forms, and templates) to identify areas impacted by the new PLM system.Update, rewrite, and reorganize documents to align with revised PLM workflows, system capabilities, and quality requirements.Ensure all changes comply with applicable regulatory, quality, and internal standards.Collaborate with process owners and subject matter experts (SMEs) to ensure documentation is accurate, complete, and easy to understand.Ensure updates across related QMS documents are implemented consistently and supporting documents remain aligned.Navigate the change control process to ensure documentation changes are released by the system go-live date.PLM Implementation SupportPartner with the project team to understand new or updated PLM system functionality.Translate system behavior and process flows into clear, user-friendly documentation.User Acceptance Testing (UAT)Assist in creating UAT test scripts and acceptance criteria based on future-state processes.Support execution of UAT by documenting test results, identifying defects, and tracking resolution.Collaborate with functional leads to validate that system behavior aligns with business requirements.Training MaterialsDevelop or enhance training materials, including job aids, quick reference guides, SOP walkthroughs, and presentation decks.Create clear, task-based instructions that guide end users through new PLM processes and system functionality.Work with the training team and SMEs to validate the accuracy and usability of training materials.Support onboarding and training sessions by capturing feedback and providing clarifications as needed.EducationBachelor's degree in Science, Engineering, Business, or a related discipline.Experience working in a regulated environment (cGMP, cGDP, and 21 CFR Part 11) preferred.Qualifications & ExperienceExperience updating and maintaining Quality Management System (QMS) documentation in a regulated environment.Familiarity with Product Lifecycle Management (PLM) systems.Strong technical writing skills with exceptional attention to detail.Ability to translate complex processes and system tasks into clear, concise, user-friendly documentation.Experience supporting User Acceptance Testing (UAT) activities or writing test scripts.Strong communication and cross-functional collaboration skills.Stakeholder communication and customer service experience preferred.Ability to work independently while managing multiple priorities.RegardsVishnu Das Natesandvishnu@radiants.com