Document Control Specialist

Amick Brown, LLC Sunnyvale , CA 94089

Posted Yesterday

Amick Brown is seeking an experienced Document Control Specialistfor our direct client.Location: Sunnyvale, CADuration: 1 YearJob Description
  • Implements and maintains an Engineering Change Notice System.
  • These changes will include product improvements, repairs, and new product development.
  • Coordinates the interaction between engineering, manufacturing, field operations, and marketing to ensure appropriate changes are documented.
Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing.The company was founded in 2010 and is headquartered in San Ramon, California.Regular full-time employees are eligible for the following Amick Brown provided benefits:
  • Health
  • Vision
  • Dental
  • 401k with company match
  • Paid time off
  • Sick Leave
  • Short-Term Disability
  • Life Insurance
  • Wellness & Discount Programs
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Document Control Specialist 3
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Amick Brown, LLC

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VIEW JOBS 10/1/2022 12:00:00 AM 2022-12-30T00:00 <span><span sans-serif""=""><span>Amick Brown is seeking an experienced</span><b><span>Document Control Specialist 3</span></b> for <span>our direct client</span><span>.</span></span></span><br><span><span sans-serif""=""><b><span>Location</span></b><span>Sunnyvale</span>, <span>CA</span></span></span><br><span><span sans-serif""=""><b><span>Duration:</span></b><span> 12 Months</span></span></span><span><span sans-serif""=""><b>Description</b></span></span><br><span><span sans-serif""=""><b><span>Primary Function of Position</span></b></span></span><ul><li align="left" style="text-align:left; margin-top:1px; margin-left:8px"><span><span sans-serif""=""><span>The Document Control Specialist 3 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. </span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>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). </span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>This role requires sedentary and repetitive working conditions.</span></span></span></li></ul><span><span sans-serif""=""><b><span>Roles & Responsibilities</span></b></span></span><ul><li align="left" style="text-align:left; margin-top:1px; margin-left:8px"><span><span sans-serif""=""><span>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</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Audit changes for accuracy and completion. Review changes to ensure that language used in the change is adequate and in compliance. Ensure that changes are in a closed loop and all discrepancies (if any) are addressed and closed before the change is released</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Provide clear and accurate communication to internal customers. Clearly communicate both verbally and in writing, with Originators when discrepancies are found. Give precise guidance to originators for the proper process to follow when to correct issues/discrepancies.</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Provide Agile and change procedure training support as needed to co-workers within and outside Document Control</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Promptly respond to questions and issues raised by Originators and Approvers</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Work with ECO Coordinator to select changes for CCB meetings based on production impact</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Represent Document Control at CCB meetings</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Work with ECO Coordinator and Originators in following-up, analyzing and helping to resolve open ECO/MCO issues</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Provide continuous improvement of Document Control processes/procedures in accordance with department and company goals</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Familiarity with Design History requirements and documents</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Experience with and, clear understanding of the Quality System Regulations and ISO 13485 requirements</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Lead/participate in projects/assignments that support continuous improvement efforts and department/company goals</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Provide change control training (processes and system) to users</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Maintain change control training materials up to date</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Create and maintain change control metrics and reports</span></span></span></li></ul><span><span sans-serif""=""><b><span>Required Skills</span></b></span></span><br><span><span sans-serif""=""><b><span>Education</span></b></span></span><ul><li align="left" style="text-align:left; margin-top:1px; margin-left:8px"><span><span sans-serif""=""><span>High school diploma</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>College degree is preferable</span></span></span></li></ul><span><span sans-serif""=""><b><span>Experience</span></b></span></span><ul><li align="left" style="text-align:left; margin-top:1px; margin-left:8px"><span><span sans-serif""=""><span>5+ years’ experience working in Document Control in a Regulatory or Quality organization with a minimum of 3 years at medical device company</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Experience processing changes using an electronic documentation system</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Proficient using Word and Excel applications, and Windows operating system</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Experience using Agile</span></span></span></li></ul><span><span sans-serif""=""><b><span>Skills</span></b></span></span><ul><li align="left" style="text-align:left; margin-top:1px; margin-left:8px"><span><span sans-serif""=""><span>Must be able to work effectively in a fast paced, team oriented environment</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Ability to work independently with minimal supervision</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Demonstrated ability with database applications. Proficient using Word and Excel application, and Windows operating system</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Demonstrated cross-functional teamwork skills</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Self-starting, detailed oriented, and ability to focus on task at hand</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Ability to work independently with multiple departments to resolve Document Control issues</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Well-developed English written and verbal communication skills</span></span></span></li></ul><span><span sans-serif""=""><b><span>Training (Preferable)</span></b></span></span><ul><li align="left" style="text-align:left; margin-top:1px; margin-left:8px"><span><span sans-serif""=""><span>Product Lifecycle Management (PLM) Processes and System</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Change Control Management</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Quality System Regulations</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>ISO 13485 2016</span></span></span></li></ul><span><span sans-serif""=""><span>Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California.</span></span></span><br><span><span sans-serif""=""><span>Regular full-time employees are eligible for the following Amick Brown provided benefits: </span></span></span><ul><li align="left" style="text-align:left; margin-top:1px; margin-left:8px"><span><span sans-serif""=""><span>Health</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Vision</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Dental</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>401k with company match</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Paid time off</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Sick Leave</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Short-Term Disability</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Life Insurance</span></span></span></li><li align="left" style="text-align:left; margin-left:8px"><span><span sans-serif""=""><span>Wellness & Discount Programs</span></span></span></li></ul> Amick Brown, LLC Sunnyvale CA

Document Control Specialist

Amick Brown, LLC