Document Control Specialist

HeartFlow, Inc. is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the HeartFlow FFRCT Analysis—provides a color-coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. HeartFlow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.

HeartFlow is a VC-backed, pre-IPO company that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 250,000 patients worldwide.

The Document Control Specialist will manage the electronic document management system (EDMS) and support the organization’s use of the system for documents, records, and training. In this role, he/she will be required to interact with employees at all levels of the organization, providing assistance and instruction. A sharp eye for detail, exceptional organizational skills, strong editing and proofreading skills, the ability to learn and superb time-management skills to prioritize multiple deadlines are all necessary to succeed in this role. Document Control Specialists must be able to recognize problems, recommend solutions and put the solutions into action. They must also be able to maintain confidentiality as they interact with all levels of an organization.

Job Responsibilities:

• Support the quality management system through management of the electronic document control and training system, including but not limited to:
  • Collaboration with cross functional department to train, coach, and help facilitate the processing of change requests, document changes/ updates
  • Management of various internal documents while also ensuring their accuracy, quality, and integrity
  • Training assignment for new hires, manage training assignments for role/department changes
  • Management of training roles to support training compliance
  • Organization of the data for ease of location / access
• Recurring and on-demand generation of reports frequently requiring data verification
• Drive awareness of delayed approvals to assist documents through the process
• Drive awareness of late training completion to individuals and management to assist in training compliance
• Support quality system audits; be the audit expert for the EDMS
• Manage/participate in projects/assignments that support continuous improvement efforts and department and goals as assigned by Quality Management
• Other duties as assigned

Skills Needed:

• Excellent communication skills
• Self-starter, the ability to multi-task and troubleshoot
• Strong analytical skills / problem solving abilities
• Excellent organization skills and attention to detail ability to work in a faced paced environment.
• Dependable and trustworthy, with a common sense
• Proficiency in computer software applications and prior experience with Confluence or other EDMS required

Educational Requirements & Work Experience:

• Bachelor’s Degree preferred
• 1-2 years of experience with document management utilizing EDMS systems
• 1-2 years of experience working in a regulated industry preferred
• Knowledge of ISO 13485 preferred

This position has an estimated base salary of $55,000-$77,000 per year, cash bonus, and stock options.