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Job Title:

Document Control Specialist II - Sunnyvale, CA

Job Description:

Document Control Specialist II 

Primary Function of Position: 
The Document Control Specialist III is responsible for assisting the Document Control lead and manager in maintaining and continuously improving the Document Control Quality System in order to support the business and release of marketed products, meet regulations and established requirements. Ensures that product and product related documents are processed through the Agile database in compliance with established procedures, Engineering Change Orders (ECOs), Manufacturing Change Orders (MCOs), Deviations and Engineering Change Requests (ECRs). 

Roles and Responsibilities: 

  • Process documentation changes in Agile: Ensure electronic capture and retrieval of quality documents and records by reviewing, evaluating and processing changes accurately and in a timely manner while ensuring that they meet the department goals and objectives
  • Audit changes for accuracy and completion
  • Provide guidance and communication to Originators in order to share best practices and resolve change issues and/or discrepancies
  • Provide Agile and change procedure training support as needed to co-workers within and outside Document Control
  • Promptly respond to questions and issues raised by Originators and Approvers
  • Work with ECO Coordinator to select changes for CCB meetings based on production impact
  • Represent Document Control at CCB meetings
  • Work with ECO Coordinator and Originators in following-up, analyzing and helping to resolve open ECO/MCO issues
  • Provide continuous improvement of Document Control processes/procedures in accordance with department and company goals
  • Familiarity with Design History requirements and documents
  • Experience with and, clear understanding of the Quality System Regulations and ISO 13485 requirements
  • Lead/participate in projects/assignments that support continuous improvement efforts and department/company goals
  • Assist LMS Administrator as the department back-up for all LMS Regulatory Affairs department work/issues
  • Assist Document Control Agile Administrator in management of user accounts

Skill/Job Requirements 
Minimum requirements in order to adequately perform the responsibilities of this position 

Education 

  • Four year college degree is preferable

     

    Experience

  • 5+ years’ experience working in Document Control in a Regulatory or Quality organization with a minimum of 3 years at medical device company
  • Experience processing changes using an electronic documentation system
  • Proficient using Word and Excel applications, and Windows operating system
  • Experience using Agile

 

Skills 

  • Must be able to work effectively in a fast paced, team oriented environment
  • Ability to work independently with minimal supervision
  • Demonstrated ability with database applications
  • Demonstrated cross-functional teamwork skills
  • Self-starting, detailed oriented, and ability to focus on task at hand
  • Ability to work independently with multiple departments to resolve Document Control issues
Well-developed English written and verbal communication skills

Job ID:
327136

Dept ID:
10573

Location:
Sunnyvale, CA
United States of America

Industry:
Online / Full App

Job Type:
Temp Position
Folder Group ID
258

Posted Date:6/1/2018

Domain:arna

Contact: lisa.burns@advantageresourcing.com

Apply for this Position

Job Title: Document Control Specialist II

Location: Sunnyvale, CA

Job Type: Temp Position

Reference ID: 327136

Posted Date: 6/1/2018

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