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Lead Project Estimator
3 months ago
Document Control AnalystJob ID:
Competitive Pay Rate:
Location-based
Approved Locations: 100% onsite; Sunnyvale, CADuration: Initial 12-month contract; extensions/conversion based on performanceStart: Targeting May 2024Benefits: Medical, dental, vision, disability + PTO & sick time available
Job Description:
The Document Control Analyst will support product programs by managing Standard Operating Procedures, Work Instructions, Forms, and all types of Records from product concept through obsolescence.
The Document Control Analyst has knowledge and experience working in regulated environments (i.e. ISO and sufficient knowledge and experience to be able to operate with minimal supervision. You are flexible, responsive, detail oriented, hands-on and able to manage competing demands.Responsibilities:
Support Reality Labs Quality Management System documentation and records through the product lifecycleCreate and release documents based on input from quality and compliance teams to support new product introduction, production product releases and clinical trials and FDA submissionEnsure documentation and data related to the requirements of the Quality System are controlled in a manner which ensures integrity and accessibilityEnsure document control activities such as document management, version control, distribution and reporting management are executed in a timely fashion and in accordance with regulatory requirementsCollaboratively communicate documentation and records requirements between Operations, Supply Chain and Engineering to facilitate compliance to applicable medical devices standardsMaintenance of all applicable records such as validation reports, test reports, exit reviews, test results, as defined by applicable regulations and standardsSupport audits for licensure and accreditation documents submissionSupport the maintenance of periodic document reviewManage and organize complex projects and priorities, solve problems that impact release progress and provide detailed information to cross functional teamsSupport the implementation of new eQMSEnd user support and problem resolutionQualifications (Must have)
Experience working on a regulated Medical Device environment (Thermofisher preferred)(Must have) Electronic document management system (Teamcenter/Oracle Agile preferred)(Must have) Familiarity with ISO years of related experience in a high tech, fast paced, consumer electronics environment managing medical device Quality Management System documentation and resulting recordsExperience with Teamcenter or related PLM/Document Management systemsFamiliarity with Google SuiteNote from HM:
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