Lead Quality Engineer

Job description

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

The Lead Quality Engineer will work in a multidisciplinary team of subject-matter-experts in the development and sustaining of Tempus’ In Vitro Diagnostics (IVD) medical devices and Laboratory Developed Test (LDT) products. This is a hands-on role where the Lead Quality Engineer will apply diversified knowledge mainly in the areas of product development, risk management, and post-market surveillance, as well as overall and quality principles and practices throughout the entire lifecycle of Tempus’ regulated products.

Responsibilities include the following:

• Responsible for implementation of quality assurance principles and practices for design, development, manufacturing, and lifecycle management of Tempus’ assay products, including medical devices and lab developed tests (LDTs). 

• Responsible for core team oversight of Class 3 US FDA and Class C EU IVDR compliance, including pre-market development and post-market surveillance (PMS) activities, across multiple devices.

• Responsible for ownership of the EU PMS framework and related deliverables, specifically PMS plans, periodic safety update reports, post-market performance follow up plans and reports, and other required activities and documentation.

  This is an excerpt. Read the full job description on Tempus careers →