ProTech is seeking 3 Document Control Specialists for a contract opportunity for our client in Memphis, TN. Can work from Memphis or Pittsburg from their home location.
Assists with the successful implementation of Global QMS documents impacted by EUMDR to the 7 manufacturing sites Directly work with the manufacturing sites with implementing the EUMDR Impacted Global Implementation Projects Assist sites with Gap Assessments, redlining local documents to reflect MDR needs and reviewing local QMSs for MDR compliance Leads or supports the update and cross functional reviews of Quality System procedures including obtaining, analyzing and incorporating stakeholder feedback, processing ECRs and ECOs, delivering process training and tracking process performance Supports the collection, analysis and reporting or management review inputs and tracks management review actions to completion Partners with Global Training to ensure requirements for Global QMS Training are fulfilled
Create, edit, and format policies, procedures, forms, templates, work instructions and other documents as needed for the Global Quality Management System, EU MDR Manage multiple document creation projects at a time. Organize and incorporate suggested changes and edits from multiple subject matter experts. Coordinate with the implementation team to maintain deadlines Assist manufacturing sites with doing Gap Assessments, redlining local documents and preparing them for MDR Certification Audits Compile and maintain master records using electronic and/or paper systems. Maintain document control best practices for each document project Capture document lifecycle and relevant data for each project using MS Excel Other QMS documentation responsibilities as needed
Education and Experience Requirements:
Associates Degree or equivalent work experience 5+ years' technical writing; 2+ year's document control MS Office, Excel, Document Control software Travel Requirements: 10–25% 25–50%