Document Control Specialist

Quality and Regulatory Affairs Redwood City, California Austin, Texas


Description

Must be on-site to perform administrator activities.  Shifted hours (evening) to support product releases.

Job Description

This role 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, you 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.

Job Responsibilities:

  • Support the quality management system through management of the electronic document control and training system, including but not limited to:
    • Training assignment for new hires, manage training assignments for role/department changes
    • Management of training roles to support training compliance
    • Guidance and assistance to the organization in creating and routing new documents
    • 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

Skills Needed:

  • Excellent communication skills
  • Self-starter with ability to multi-task and troubleshoot
  • Strong analytical skills / problem solving abilities
  • Excellent organization skills and attention to detail
  • Dependable and trustworthy, with a lot of 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 working in a regulated industry preferred
  • Knowledge of ISO 13485 and/or QSRs preferred

About HeartFlow, Inc.

HeartFlow, Inc. is a medical technology company redefining the way heart disease is diagnosed and treated. Our non-invasive HeartFlow FFRct Analysis leverages deep learning to create a personalized 3D model of the heart. By using this model, clinicians can better evaluate the impact a blockage has on blood flow and determine the best treatment for patients. Our technology is reflective of our Silicon Valley roots and incorporates decades of scientific evidence with the latest advances in artificial intelligence. The HeartFlow FFRct Analysis is commercially available in the United States, Canada, Europe and Japan. For more information, visit www.heartflow.com.

HeartFlow, Inc. is an Equal Opportunity Employer. This company does not and will not discriminate in employment and personnel practices on the basis of race, sex, age, handicap, religion, national origin or any other basis prohibited by applicable law. Hiring, transferring and promotion practices are performed without regard to the above listed items.

Positions posted for HeartFlow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.