Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 201051
Responsible for assisting the Document Control Management in leading the Document Control team’s maintenance and continuous improvement of the Document Control Quality System in order to support the business, release of marketed products and meet regulations and established requirements. This includes project leadership of improvement activities for the document management system (Agile) and training of the system to both Document Control personnel and ISI employees. Having solid knowledge on Engineering validation and qualification concept and process. Work to ensure that product and product related documents are processed through the Agile database in compliance with established procedures, Engineering Change Orders (ECOs), BETA CHANGE ORDER (BCO), CLINICAL CHANGE ORDER (CCO), Manufacturing Change Orders (MCOs), Deviations and Engineering Change Requests (ECRs).
- Manage new user accounts and delete terminated users
- Maintain/improve signature matrix, including creating new categories and approval groups per request.
- Maintain data integrity within the form fields and update item forms within Agile to accommodate changes within company processes and company growth
- Have in-depth Agile system and change control processes knowledge in order to “trouble shoot” issues as needed and know when to escalate them to IT
- Understand how Agile links to other systems within and outside ISI
- Have a clear understanding as to how Agile is used in other departments and functional areas within Intuitive, as well as at other Intuitive sites and supplier locations
- Document appropriate changes to system functionality and processes
- Maintain/improve Document Control procedures as needed
- Process changes according to documented procedures
- Assist project lead for system changes and other Document Control projects
- Mentor Document Control team members as needed
- Provide training to new hired Change Analyst as needed
- Provide training to new suppliers as needed
- Responsible for history and archiving processes of QS data
- Assist Document Control management in providing guidance to DC Specialists on daily process and as needed.
- Represent Document Control on projects as needed.
- Be available for other duties/projects as needed
- Oversee and coordinate Document Control training activities. Ensure all Document Control Specialists are trained to new deployed processes
- Execute test scripts to support Document Control project improvements.
- Provide Learning Change Request (LCR) Training to Managers and Manage the archive of training record activities as required
Minimum requirements in order to adequately perform the responsibilities of this position
- Four year college degree, preferred
- Minimum of 5+ total years’ experience working in Document Control in a Regulatory/Quality organization in a medical device company with a minimum of 3 years as a Lead or Supervisor preferred
- Experience with a Learning Management System and its links to Document Control processes, preferred
- Experience in developing training aids and delivering technical training to a cross functional audience
- Solid understanding of Quality System Regulations and ISO requirements
- Familiarity with Design History requirements
- Demonstrated practical experience in AGILE system, processes and documentation
- Excellent customer service skills
- System project management experience preferred
- Must be able to work effectively in a fast paced, team oriented environment
- Ability to work independently without supervision
- Demonstrated ability with database applications especially Microsoft Office Suite, including Microsoft Project
- Demonstrated ability to build cross functional consensus for changes and to achieve project goals
- Self-starting, detailed oriented, and ability to focus on task at hand
- Ability to work independently with personnel from multiple departments in order to resolve Document Control issues
- Well-developed English written and verbal communication skills
We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.