Document Specialist III
3 weeks ago
Location: Sunnyvale CA
Duration: 1 year contract with possibility of extension.
Start: Targeting May 2024
Benefits: 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 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 lifecycle.
- Create and release documents based on input from quality and compliance teams to support new product introduction, production product releases and clinical trials and FDA submission.
- Ensure documentation and data related to the requirements of the Quality System are controlled in a manner which ensures integrity and accessibility.
- Ensure document control activities such as document management, version control, distribution and reporting management are executed in a timely fashion and in accordance with regulatory requirements.
- Collaboratively communicate documentation and records requirements between Operations, Supply Chain and Engineering to facilitate compliance to applicable medical devices standards.
- Maintenance of all applicable records such as validation reports, test reports, exit reviews, test results, as defined by applicable regulations and standards.
- Support audits for licensure and accreditation documents submission.
- Support the maintenance of periodic document review.
- Manage and organize complex projects and priorities, solve problems that impact release progress and provide detailed information to cross functional teams.
- Support the implementation of new eQMS.
- End 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 records.
- Experience with Teamcenter or related PLM/Document Management systems.
- Experience working on a regulated Medical Device environment.
- Familiarity with Google Suite
- Familiarity with ISO 13485
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