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Change Analyst
Ref No.: 18-47592
Location: Santa Ana, California
Position Type:Full Time/Contract
Start Date: 07/09/2018
Change Analyst
Santa Ana, CA
Fulltime Permanent


Technical/Functional Skills:
Excellent knowledge on authoring procedures
Working knowledge on creating documents and managing document workflows
Must be comfortable handling multiple tasks/projects and capable of managing priorities accordingly
Must have authored procedures, work instructions, quality forms and templates
Understands the linkages in quality systems
Excellent verbal and written communication and interpersonal skills
PC skills, MS Office tools like WORD, EXCEL, PowerPoint is a must

Experience Required :
Prior experience in medical device industry/ Aerospace industry/ Pharma industry is a must
Experience on document control systems preferably Agile system
Experience in creating, reviewing Engineering Change Orders and Document Change Requests.
Technical Documentation with Medical Device & Pharmaceutical Industry experience.
Skilled in the management, creation, and review of Quality and Engineering documentation.
Experience in creating Standard Operating Procedures (SOPs), engineering documentation.
In-depth experience ensuring compliance with ISO and FDA Quality System Regulations.
Project management and co-ordination with extended teams

Roles & Responsibilities :
Responsible for coordinating the changes and modifications in the documents
Understand the document change control process and execute the changes appropriately
Work with all stakeholders to understand the requirements of changes and document them regularly
Facilitate and organize meetings with all stakeholders to achieve desirable outcomes
Follow-up with approvers to ensure timely closure of the projects
Performs other related duties as assigned by management.