Document Control Specialist - Sunnyvale, CA - 18-02234

Job Description

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 Moiz at 408-816-2442. If this position is not quite what you're looking for, visit akraya.com and submit a copy of your resume. Our team will get to work finding you a job that is a better match at one of our many clients.

Skill/Job Requirements:

Minimum requirements in order to adequately perform the responsibilities of this position

Education

* High school diploma

* Two years college, however four year college degree is preferable

Experience

* 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

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

* 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

Please apply directly with your updated resume or call Moiz at 408-816-2442

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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