Document Control Specialist 2

Intuitive • Sunnyvale, CA

18h

About The Position

Primary Function of Position Document Control Specialist 2 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. Ensure that product and product related documents are processed through the Agile database in compliance with established procedures. This includes simple to moderately complex Engineering Change Orders (ECOs), Manufacturing Change Orders (MCOs), Clinical Change Orders (CCO), and Beta Change Orders (BCO). This role requires sedentary and repetitive working conditions.

Requirements

• Experience processing changes using an electronic documentation system
• Proficient using Microsoft Office applications, and Windows operating system
• Must be able to work effectively in a fast paced, team-oriented environment
• Self-starting, detailed oriented, and ability to focus on task at hand
• Ability to work independently with multiple departments to resolve Document Control issues
• Well-developed English written and verbal communication skills
• Good understanding of Quality System Regulations and ISO requirements
• University degree with 2 years of experience working in Document Control in a Regulatory or Quality organization at a medical device company, or 4 years of equivalent work experience
• Quality System Regulations and ISO 13485 requirements

Nice To Haves

• Project Management
• Agile Lifecycle System
• Change Control Management

Responsibilities

• Process moderately complex change orders 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 to follow up, analyze, and resolve open change order issues
• Raise issues applicable to the Document Control team and offer solutions. Provide status where applicable.
• Perform additional project tasks as needed under minimal supervision

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level