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Quality Systems Change Analyst - 58054839 - TT

Job Code: 58054839
Job Location: Brea, CA
Category: Quality Engineering
Last Updated: 07/21/2017
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Job Description:
The Global Quality Systems Change Analyst assists in the review, release, and implementation of global quality documents via the change order process. The GQS Change Analyst ensures documentation and record keeping processes conform to all applicable internal procedures and external medical device regulatory requirements. The individual will assist in the day-to-day document control activities within the Global Quality Systems documentation team.  
Job Duties:
• Performs document control functions by initiating change orders to effectively route, track, process, review, distribute, release, and archive documents
• Collaborates with cross-functional teams and Global Process Owners in the timely release of documents via the change order process
• Organizes and ensures accurate and reliable document requests using SharePoint
• Provides a thorough review of document content prior to routing to ensure adherence to internal processes
• Works closely with translation agency to coordinate document translations
• Adheres to internal processes and provides input for process improvement
• Proactively initiates, develops, and maintains effective working relationships with team members
• Other duties as assigned
 
Requirements
• Bachelor’s degree in scientific discipline or an equivalent combination of skills, education, and experience
• Quality professional with 3-5 years of experience with document management in a regulated industry – pharmaceutical or medical device industry – with direct document control and change order system experience
• Excellent analytical, verbal communication and writing skills
• Self-starter able to manage multiple competing demands
• Proficient at reviewing and editing documentation
• High-level critical thinking and problem solving skills
• Skilled in the use of a Product Lifecycle Management (PLM) system, MS office applications such as Word, Excel, PowerPoint and Adobe Acrobat
• Self-motivated with ability to implement, organize and prioritize multiple tasks to meet deadlines
• Ability to effectively build and maintain relationships with all levels of management
• Knowledge of industry regulations to include 21 CFR 11, ISO 13485, ISO 9001, Good Documentation Practice (GDP)
Preferred Skills
• Technical writing or copy editing background
• Experience working with translations and localization of written content
 
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or engineeringteam@entegee.com.
 
Please reference job # 58054839TT
 
Equal Opportunity Employer
Minorities/Women/Veterans/Disabled
 
 


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Entegee is an equal opportunity employer. Entegee considers applicants for all positions without discrimination on the basis of race, color, religion, sex, national origin, age, marital or veteran status, disability, or any other legally protected status. No question in the website is used for the purpose of limiting or excluding any applicant's consideration for employment on any basis prohibited by local, state, or federal law.

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