DOCUMENT CONTROL SPECIALIST 3

Company: TalentBurst, Inc.
Location: Sunnyvale
Posted on: May 24, 2023

Job Description:

Job Title: Document Control Specialist 3
Location: Sunnyvale Ca 95051
Duration: 12 Months
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Job Description
Primary Function of Position:
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 tsupport 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). This role requires sedentary and repetitive working conditions.
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Roles & 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. Review changes tensure 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
Provide clear and accurate communication tinternal customers. Clearly communicate both verbally and in writing, with Originators when discrepancies are found. Give precise guidance toriginators for the proper process tfollow when tcorrect issues/discrepancies.
Provide Agile and change procedure training support as needed tco-workers within and outside Document Control
Promptly respond tquestions and issues raised by Originators and Approvers
Work with ECCoordinator tselect changes for CCB meetings based on production impact
Represent Document Control at CCB meetings
Work with ECCoordinator and Originators in following-up, analyzing and helping tresolve open ECO/MCissues
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 IS13485 requirements
Lead/participate in projects/assignments that support continuous improvement efforts and department/company goals
Provide change control training (processes and system) tusers
Maintain change control training materials up tdate
Create and maintain change control metrics and reports
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Skills, Experience, Education, & Training:
Education
High school diploma
College degree is preferable
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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
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Skills
Must be able twork effectively in a fast paced, team oriented environment
Ability twork independently with minimal supervision
Demonstrated ability with database applications. Proficient using Word and Excel application, and Windows operating system
Demonstrated cross-functional teamwork skills
Self-starting, detailed oriented, and ability tfocus on task at hand
Ability twork independently with multiple departments tresolve Document Control issues
Well-developed English written and verbal communication skills
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Training
(Preferable)
Product Lifecycle Management (PLM) Processes and System
Change Control Management
Quality System Regulations
IS13485 2016

Keywords: TalentBurst, Inc., Sunnyvale , DOCUMENT CONTROL SPECIALIST 3, Other , Sunnyvale, California