Quality Engineer

At Tempus, the Quality Engineer is pivotal to ensuring our medical devices and diagnostics meet the highest standards of quality. Responsibilities include implementing quality assurance principles during design and maintenance of products, managing product risk throughout the lifecycle, conducting quality assurance reviews, participating in audits, and supporting documentation and change management processes.

To join Tempus as a Quality Engineer, candidates should have a Bachelor's degree in a relevant engineering field like Biomedical or Chemical Engineering, along with a minimum of 2 years’ experience in the Medical Device or Pharmaceutical industry. Knowledge of FDA regulations and international standards such as ISO 13485 and 21 CFR 820 is also crucial.

The Quality Engineer position at Tempus is primarily onsite in Chicago. However, it is essential to review the latest communication from our HR department regarding any flexible working arrangements, as some roles may consider hybrid or remote options depending on departmental needs.

Quality Engineers at Tempus work with various tools and eQMS systems such as Jama, ETQ, and Pilgrim SmartSolve. Proficiency in Microsoft Office applications like Word, PowerPoint, and Excel is also expected to facilitate effective project documentation and communication.

Working at Tempus as a Quality Engineer is unique because you're not just ensuring compliance—you're actively contributing to cutting-edge healthcare innovations. You will engage in meaningful projects that directly impact patient outcomes while collaborating with a talented team dedicated to advancing precision medicine.

When discussing your experience in quality assurance, highlight specific projects where you've implemented or managed quality processes. Share examples that demonstrate your understanding of regulatory requirements and how you've ensured adherence to standards like ISO 13485 or FDA regulations.

Addressing changes effectively requires good communication and a structured approach. Explain how you've previously managed change by coordinating with stakeholders, assessing potential impacts, and ensuring all changes are correctly documented and communicated to the team.

Use the STAR method (Situation, Task, Action, Result) to discuss a quality issue you encountered. Focus on how you investigated the problem, collaborated with your team, and implemented solutions that resulted in improved quality outcomes.

Discuss specific risk management frameworks you've applied such as FMEA (Failure Mode and Effects Analysis) or HACCP (Hazard Analysis and Critical Control Points). Explain how you identify risks early and engage with cross-functional teams to mitigate them through proactive planning.

Talk about your approach to compliance, emphasizing the importance of staying updated with regulations like the EU IVDR/MDR and 21 CFR 820. Discuss how you have established compliance protocols and engaged in continuous education and training within your team.

Highlight the significance of maintaining thorough and accurate documentation in a regulated environment. Discuss your strategies for organizing documentation systematically and utilizing eQMS platforms to ensure all records are easily accessible and compliant.

Explain your audit preparation process, including how you ensure your projects and teams are audit-ready. Share experiences of past audits, the roles you've played in addressing findings, and how you've used audits as opportunities for improvement.

Discuss how you analyze quality metrics to identify trends and areas needing enhancement. Provide a specific example illustrating how acting on data insights led to tangible improvements in product quality or process efficiency.

Detail your experience conducting root cause analyses using methodologies like the 5 Whys or Fishbone Diagram. Showcase how identifying root causes led to effective corrective actions that prevented recurrence of quality events.

Demonstrate your organizational skills by explaining how you assess project timelines and criticality. Share examples of using prioritization frameworks to manage multiple responsibilities without compromising quality.