Manage the change control system (Cloud PLM); Review, route, assess training impact and release change orders. Assist in Cloud PLM software training and other training as required. Ensure projects are completed accurately and on time. Able to interact with internal and external customers. Support Quality in both external and internal audits. Monitoring status of in-process document changes to ensure timely revisions. Assist customers with problem solving and offer possible solutions utilizing understanding of the job and applies knowledge and skills to complete a wide range of tasks. Scan, archive and retrieve quality documents and records. Issues controlled and uncontrolled documents. Maintain service records of all departments. Prepare requests for reproduction of documents. Maintain external standards in accordance with standard operating procedures. Support the development of documentation and configuration control procedures. Support the testing and improvement of the change control software and other supporting software. Generate Quality Assurance reports as needed. This position assumes and performs other duties as assigned. Able to work in shift. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Minimum of 2+ years related experience and/or training; or equivalent combination of education and experience Proficient with Microsoft Office Suite Ability to create reports in support of other Quality Assurance systems. Ability to use critical thinking and resolve issues. Knowledge of electronic documentation systems. Good understanding of Document Control requirements and processes as outlined in ISO 13485 and 20 CFR part 820. Must have the ability to apply acquired knowledge of GDP and GMP to daily tasks. Experience with Cloud PLM Document Control system Post Graduate Diploma/Professional Degree in Business Studies/Administration/Management, or equivalent.
