Client Documentation Assistant I

Years of Experience: 15

Education & Licenses:

  • Graduated with honors, 1969, Marietta High School, Marietta, OH
  • AAMI training on FDA regulations, Danaher Corporation, 2012
  • ISO 9001 audit and standard training, BSI, 2010
  • System Administration certification for MasterControl document control and regulatory software, MasterControl Corporation, 2008

Areas of Specialization:

  • Document Control
  • Quality Procedure Development and Revision
  • Microsoft Office, MasterControl Database, Oracle, Teamcenter
  • ISO 9001

Overview:

Ms. Bleakley is a Client Documentation Assistant with the Practices Team at E2G | The Equity Engineering Group, Inc.  Prior to E2G, Ms. Bleakley worked as a Project Engineer, during which time she supported engineering change analysis, organized projects for notifications of actions for internal and external customers, designed spreadsheets to track actions, and created detailed work instructions for notification actions.  She has also worked as a Quality Manager, during which time she oversaw integration of an acquired product line into the QA department and helped maintain facility compliance with regulatory requirements (FDA and nuclear) as well as with ISO 13485, 9001, and 17025.  As Quality Coordinator, Ms. Bleakley coordinated the internal audit program, which included writing and resolving CAPAs, and wrote and revised quality procedures.  During her time as a Document Control Coordinator, she processed engineering change requests and updated bills of material.