Document Control Specialist 3

Intuitive Surgical • Sunnyvale, CA

72d

About The Position

The Document Control Specialist 3 is responsible for maintaining and continuously improving the Document Control Quality System in order to support the business and release of marketed products, meet regulations and established requirements. Ensures that product and product related documents are processed through the Agile database in compliance with established procedures. This includes complex Engineering Change Orders (ECOs), Manufacturing Change Orders (MCOs), Clinical Change Orders (CCO), Beta Change Orders (BCO), and Deviations. This role requires sedentary and repetitive working conditions.

Requirements

• University degree with 3 years' experience working in Document Control in a Regulatory or Quality organization, or 6 years relevant work experience with a minimum of 3 years at medical device company
• Experience processing changes using an electronic documentation system
• Proficient using Microsoft Office applications, and Windows operating system
• Experience using Agile
• Product Lifecycle Management (PLM) Processes and System (preferable)
• Change Control Management
• Quality System Regulations
• ISO 13485 2016
• High school diploma
• College degree is preferable

Nice To Haves

• Project Management
• Agile Lifecycle System

Responsibilities

• Process documentation changes accurately and timely using the electronic documentation system.
• Audit documentation changes for accuracy, completeness, and compliance with language and regulatory requirements.
• Ensure changes are in a closed loop with all discrepancies addressed before release.
• Provide clear verbal and written communication to internal customers, including guidance to originators on correcting issues or discrepancies.
• Promptly respond to questions and issues raised by Originators and Approvers
• Collaborate with ECO Coordinators and originators (including senior and external subject matter experts) to follow up, analyze, and resolve open change order issues
• Raise issues applicable to the Document Control team and offer solutions and alternatives with justification for actions.
• Select methods and techniques for obtaining solutions
• Independently perform routine project tasks within limited scope

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: High school or GED
• Number of Employees: 1-10 employees