Quality Assurance Specialist

Job description

Work Location : Sunnyvale, CA Pay Range : $71,000 - $85,000 Job Type : Full-Time Onsite: Our Company: Founded in 2010, iHealth Labs is dedicated to empowering people to live healthier lives. The company is a leading provider of cloud-connected medical devices, personal health care devices, and home-based tests, and is at the forefront of the digital health revolution. In November 2021, iHealth's COVID-19 Antigen Rapid Test received Emergency Use Authorization from the U.S. Food and Drug Administration for over-the-counter sales. Since then, iHealth has become a key supplier of at-home COVID tests to the federal government, state governments, nonprofits, and individual consumers. iHealth Labs is a leader in digital health solutions, with a mission to revolutionize the healthcare industry by making quality health management accessible and affordable for all. Key Responsibilities: Complaint Handling & Reportability Serve as primary lead for intake, evaluation, and triage of customer complaints. Assess complaints for Medical Device Reporting (MDR) requirements and determine whether further investigation is needed. Report confirmed MDRs to the FDA and escalate possible reportable compla...