Lead Quality Engineer

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.

• Responsible for identifying PMS trends for Management Review.

• Responsible for coordinating cross-functional efforts for the creation and maintenance of DHF and IVDR Technical Documentation across devices.

• Responsible for investigational device development clinical performance and lifecycle management according to US FDA and EU IVDR requirements.

• Ensure the relevance adequacy and effectiveness of Tempus’ QMS and its continuous improvement with a proactive and preventive risk-based approach.

• Implement risk management principles per ISO 14971 including consideration of  EU PMS risks.

• Maintain and execute change management process ensuring change impact and action items are appropriately evaluated tested and documented

• Apply medical device quality system knowledge as part of quality leadership including but not limited to audits nonconformances CAPAs supplier qualification etc.

• Participate in internal and external quality system audits as required

• Participate in root cause investigations as quality events/incidents arise

• Share knowledge and expertise with teammates.

• Support other duties as assigned

Qualifications 

• 5+ years of experience in the Medical Device/Pharmaceutical regulated industry.

• BS degree in Engineering field such as Biomedical Bioengineering or Chemical Engineering

• Experience with applicable FDA European and other relevant clinical/regulatory requirements international standards including ISO 13485 ISO 14971 EU IVDR/MDR and 21 CFR 820.

• Experience in managing FDA or EU pre-market development and post-market surveillance activities.

• Experience working in a fast-paced project core-team environment

• Excellent oral and written communication skills and can communicate at multiple levels in the organization

• Proficient in Microsoft Office (Word PowerPoint Excel etc.)

• Proficient in eQMS systems (Jama ComplianceQuest Pilgrim SmartSolve etc.)

• This position is onsite

Illinois Pay Range: $110000-$155000

California New York and Massachusetts Pay Range: $110000-$155000

The expected salary range above is applicable if the role is performed from California and may vary for other locations (Colorado Illinois New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits which may include incentive compensation restricted stock units medical and other benefits depending on the position.

We are an equal opportunity employer. We do not discriminate on the basis of race religion color national origin gender sexual orientation age marital status veteran status or disability status. 

What We Do

We bring together one of the world’s largest libraries of multimodal clinical and molecular data with a robust suite of AI tools to help physicians personalize care in real time connect patients with therapies and clinical trials and enable partners to accelerate discovery and development of new treatments. With ~8 million de-identified research records and 350+ petabytes of data Tempus partners with more than half of U.S. oncologists and the majority of the top 20 global pharma companies. Our teams are pioneering work across oncology neurology psychiatry cardiology and beyond—transforming how care is delivered and therapies are developed. At Tempus every role contributes to our mission: to help each patient benefit from the experiences of those who came before. For more information visit tempus.com.

Why Work With Us

We’re looking for people who can change the world. People who question the status quo and refuse to shy away from tough problems. For builders who are never done building and the learners who are never done learning. Passionate individuals with undying curiosity who want to take on one of the greatest challenges humanity has ever faced—head on.

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