Document Control Specialist : 19-00414

Sunnyvale, CA 94086

Posted: 03/21/2019 Job Category: Clinical Affairs Job Number: 11805512
Akraya is looking for a Document Control Specialist for one of our clients. If the job description below is a fit, please apply directly or call Ashu Pandey at 408-907-2228. If this position is not quite what you’ re looking for, visit akraya.Com and submit a copy of your resume. Our recruiters will get to work finding you a job that is a better match at one of our many clients.

Primary Skills: Documentation Control, Agile, SAP, Database application, medical device, Quality System Regulations, ISO 13485.
Duration:  04+ Months Contract (Possibility for Extension)
Contract Type: W2 Only

Job 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
  • Manage/participate in projects/assignments that support continuous improvement efforts and department/company goals

  • High school diploma
  • Two years college, however four year college degree is preferable
  • 3+ years of experience working in Document Control in a Regulatory or Quality organization with a minimum of 2 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
Please apply directly with your update resume or call Ashu Pandey at 408-907-2228

About Akraya
Akraya, Inc. Is an award-winning staffing firm that works with many of the leading, technology-based companies around the world. We have been ranked as one of the “ Best Staffing Firms to Temp for” by Staffing Industry Analysts on multiple occasions and are a preferred staffing vendor within numerous staffing programs. Please visit akraya.Com to search through all of our current openings or to submit your resume to our recruiting team.

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