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Change Analyst
Ref No.: 18-01257
Location: Tucson, Arizona
Change Analyst- Tucson AZ
Responsible to carry out the creation, review, revision, approval, release and implementation of change orders within the Document Control System.  
  • Ensuring that change requests submitted for processing contain all necessary information to route correctly through the document change workflows.
  • Assist in all documentation aspects of Document & Design Change Order processing per approved procedures.
  • Updating native files when the Change Owner does not have access to the native application, such as Bill of Material changes, label changes, drawing creation and/or updates, document content checking and archiving, etc.
  • Assist and facilitate the addition, removal and modification of reviewers/approvers, as well as determining who the appropriate reviewers/approvers are required.
  • Resolve all troubleshoots error messages and problem reports to ensure that changes are processed through the Document Control System correctly.
  • Resolving issues with the change creator or reviewers/approvers when a change is placed on hold or rejected.
  • Initiate Change Orders and other Agile documentation, such as redlines or screen shots as necessary in support of Quality System process/records compliance.
  • Escalate issues as necessary to manager.
  • Monitors work to ensure quality, and continuously promote Quality First Time.
  • Participate in special projects and performs other duties as required or assigned.
Formal Training/Education:
  • Associate's degree or equivalent from a two-year college or technical school required.  Equivalent combination of education and relevant work experience will be considered.
  • Two (2) years experience in electronic documentation control systems or quality systems required
  • Experience in medical devices, or other regulated industry is preferred
  • Demonstrated working knowledge of quality systems, concepts and guidelines: i.e. FDA QSR, ISO 13485 or equivalent is preferred.
Knowledge, Skills and Abilities:
  • Must have good organizational, listening, verbal and written communication skills
  • Excellent attention to detail and accuracy
  • Able to work with minimal supervision.
  • Able to multi-task and respond positively to rapidly changing priorities.
  • Must possess strong customer service skills.
  • Excellent computer skills with knowledge databases is preferred.
  • Working knowledge of Microsoft Office (World, Excel, etc.)