Job Description

Document Specialist V

Location: Sunnyvale, CA

Duration: 12 Months

Project Overview

Looking for candidates with hands-on experience in document control processes. This includes, but is not limited to:

1) Developing and implementing document control procedures

2) Managing document revisions and approvals

3) Maintaining accurate records and ensuring compliance with regulatory requirements

Overall 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
• Maintenance of all applicable records such as validation reports, test reports, exit reviews, test results, as defined by applicable regulations and standards

Mandatory Skills

• 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

Compensation:

The estimated pay range for this position is USD $48.00/Hr - USD $53.00/Hr.

Exact compensation and offers of employment are dependent on circumstances of each case and will be determined based on job-related knowledge, skills, experience, licenses or certifications, and location.

Benefits:

We offer comprehensive benefit options which vary depending on role, location, and employment type. The Talent Acquisition Partner can share more details about compensation or benefits for the specific role during the hiring process.

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