Document Control Specialist 3

Intuitive • Sunnyvale, CA

8h

About The Position

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care. Primary Function of 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