Document Specialist III
📋 Role Overview & Responsibilities
- This is a 100% ONSITE role in Sunnyvale, CA*
Document Specialist III
Summary: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 13485) 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 resolution
Minimum Qualifications:5+ 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 systemsExperience working on a regulated Medical Device environmentFamiliarity with Google SuiteFamiliarity with ISO 13485 Pay range is $36 - $41 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.
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This position is located in Sunnyvale, CA with potential relocation and sponsorship assistance depending on candidate qualifications.
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