Change Analyst I.

Careers that Change LivesA Day in the Life Responsibilities may include the following and other duties may be assigned.Processes change orders, ranging from simple-to-complex, for the creation and revision of product, process, and system designs.Reviews and analyzes change data provided by all functions and facilitates coordination of changes with applicable stakeholders, including engineering, quality, manufacturing, operations and regulatory.Manages the change order process and prepares for change approvals by stakeholders.Prepares change management status reports.Ensures customer requirements are implemented while maintaining compliance to applicable policies, procedures, regulations, and standards.Functional Skills: Change Control, Document Management, Compliance, Product Lifecycle Management, Electronic Document Management Systems, Enterprise Resource Planning (ERP) Systems.Additional Skills: Problem Solving, Detail Oriented, Cross-Functional Collaboration, Customer Service, Process Improvement, Communication.Must Have: Minimum Requirements Requires 0+ years of experience with a High School Diploma or equivalent.Nice to Have Bachelors Degree in Administrative, Engineering or similar.3 to 5 years of experience in a similar position.Advanced English.Experience in engineering Change process.Knowledge of 21CFR 820, ISO13485Knowledge of GDPS, Oracle AgileKnowledge of Microsoft Office (Excel, Power point, Word) Goal: Ensure that Change Control methods; The configuration, documentation and procedures used are appropriate for the management of all changes, in order to ensure compliance with corporate and local guidelines to avoid having any impact related to the change order, documentation that may impact the process of production.Must ensure the alignment and continuous improvement of the Quality Management System at the local and corporate level.