Document Control Specialist – US

About Viz.ai

Viz.ai is a leader in applied artificial intelligence in healthcare. We are on a mission to fundamentally improve how healthcare is delivered in the world, through intelligent software that promises to reduce time to treatment and improve access to care.

Viz.ai’s flagship product leverages advanced deep learning to communicate time-sensitive information about stroke patients straight to a specialist who can intervene and treat. We leverage the speed and accuracy of our algorithms to help connect the right patient to the right doctor at the right time, making sure patients get the life-saving treatment they need, when they need it. Viz.ai obtained a historic FDA clearance for our stroke technology and is the first AI software to receive a CMS New Technology Add-on Payment, Viz.ai has been honored with numerous awards, including being among Fast Company’s Most Innovative Companies and recognition by UCSF as the best new application of AI in digital health. Viz.ai is currently used in more than 700 hospitals.

Viz.ai is funded by top-tier Silicon Valley investors, including Green Oaks, Kleiner Perkins, Google Ventures, Threshold, CRV, Scale Venture Partners and Insight Partners.  We are currently located in San Francisco and Tel Aviv, and are expanding into Europe and the broader EMEA region.

As a member of the Quality team, you will:

• Play a key role in executing document control deliverables for medical devices; standardization of templates; maintaining standard operating procedures (SOPs), Work Instructions (WIs)  and records; reviewing eQMS documentation for accuracy and completeness
• Initiate and revise applicable Document Control SOPs, WIs and other documents as required
• Independently facilitate routing of controlled documents, including formatting, overseeing the review and approval process, tracking and issuing document numbers
• Manage and maintain the archival of documents and records such that required documentation is retrievable and files are accurate, complete and well organized
• Perform Document Control training for new and existing employees, file employee training records electronically, and follow up to ensure training is performed in a timely manner
• Manage the employee training log to ensure employees are trained on all applicable documents
• Lead the education of personnel in requirements relating to Good Documentation Practice (GDP) associated with a Quality Management System 
• Be responsible for generating training courses, issuing permissions, maintaining system architecture, troubleshooting and implementing workflows in MasterControl.
• Define, lead, and prepare on-time completion of document control deliverables
• Manage/participate in projects or assignments that support continuous improvement of the Quality System
• Represent Document Control in projects and meetings
• Responsible for maintaining a strong collaborative partnership with cross-functional team members
• Provides support for audits and regulatory agency inspections
• Complies with applicable regulations, standards, company policies, and procedures. 
• Maintains positive and cooperative communications and collaboration with all levels of employees
• Execute any and all other undefined tasks, as directed by your supervisor

You will love this job if: 

• You get excited about innovative technology that can be used to save lives.
• You enjoy an always-changing collaborative environment.
• You are looking to make a difference in the world.

Requirements: 

• Minimum 2 years of relevant medical device industry experience (includes Document Administration, Quality Assurance, regulated system administration, training development and delivery)
• Minimum 2 years of experience in GMP Quality Management Systems and GDP
• Strong competency with MS Office Suite and Google Suite
• Experience creating forms and templates, a plus
• Strong background in both written and oral communication with emphasis on effective technical training
• May be required to work evenings, off-hours, holidays or extended periods of time
• High School Degree or GED is required, a Bachelor’s Degree is a plus
• 3 years experience and working knowledge serving as the System Administrator in MasterControl electronic Quality Management System (eQMS) required
• Demonstrated understanding of Document Control process and Quality Systems as per ISO 13485
• Excellent attention to detail and accuracy working in a fast-paced environment
• Must have demonstrated initiative, accountability and the ability to manage multiple projects in parallel
• Experience with computer system validation is a plus
• Availability to work hours that accommodate foreign timezones
• Ability to travel occasionally, both international and domestic (less than 5% of the time).

Viz offers competitive benefits, including medical, dental, vision, 401k, generous vacation, and other great benefits to full-time employees.  

Viz.ai is an Equal Opportunity Employer and considers applicants for employment without regard to race, color, religion, sex, orientation, national origin, age, disability, genetics or any other basis forbidden under federal, state, or local law. If you’re applying for a position in San Francisco, review the San Francisco Fair Chance Ordinance guidelines applicable in your area.

Please click here to apply.