Sunnyvale, CA, United States (On-site) - Document Specialist III


On Site
$35 - $43
Full Time


iso 13485
Document Specialist
Medical Device
Google Suite
Supply Chain
Quality Management
System documentation
document management
user support
clinical trials
version control
new product introduction
detail oriented

Job Details

NOTE: This is a 100% On-site role. Please don't apply if you are not willing to go On-site

Document Specilist: 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

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
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
Experience working on a regulated Medical Device environment
Familiarity with Google Suite
Familiarity with ISO 13485

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About Unify Technologies, Inc.