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Quality Engineer

Tempus is advancing the healthcare industry through AI-driven insights in precision medicine. They are seeking a Quality Engineer to enhance their In Vitro Diagnostics and Laboratory Developed Test products.

Skills

  • Medical Device regulations
  • Risk management
  • Quality assurance
  • FDA compliance
  • ISO standards
  • Project management
  • Microsoft Office
  • eQMS systems
  • Analytical skills

Responsibilities

  • Implement quality assurance principles for assay products and processes.
  • Conduct product risk management activities.
  • Review quality assurance documents for correctness.
  • Engage in planning and documentation of projects.
  • Participate in quality system audits.
  • Conduct root cause investigations for quality events.
  • Support design transfer and process validation activities.
  • Monitor quality metrics and change management processes.

Education

  • BS degree in Biomedical Engineering
  • BS degree in Bioengineering
  • BS degree in Chemical Engineering

Benefits

  • Competitive salary
  • Health insurance
  • Paid time off
  • 401(k) plan
To read the complete job description, please click on the ‘Apply’ button
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Average salary estimate

$80000 / YEARLY (est.)
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$70000K
$90000K

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What You Should Know About Quality Engineer, Tempus

Are you a passionate Quality Engineer looking to drive innovation in the healthcare sector? Tempus, located in the vibrant city of Chicago, is at the forefront of precision medicine and is excited to welcome an enthusiastic Quality Engineer to its team. In this dynamic role, you'll collaborate with a multidisciplinary group of experts focused on the advancement of our In Vitro Diagnostics (IVD) medical devices and Laboratory Developed Tests (LDT) products. You’ll be deeply involved in ensuring quality assurance principles are rigorously applied, from product development to post-launch. As our Quality Engineer, you'll manage risk assessments and product changes while participating in vital audit processes and root cause investigations. Your expertise will contribute to the planning of critical documentation and the monitoring of key quality metrics. If you have at least 2 years of experience in a regulated industry and possess a BS in Biomedical or Chemical Engineering, we want to hear from you! Your communication skills will shine in this hands-on position, as you will engage with various levels of the organization and ensure our products meet all necessary compliance standards. Join us to be part of a team that impacts lives and enhances healthcare delivery through state-of-the-art technology and insight.

Frequently Asked Questions (FAQs) for Quality Engineer Role at Tempus
What responsibilities does the Quality Engineer have at Tempus?

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.

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What qualifications are needed to become a Quality Engineer at Tempus?

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.

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Does Tempus offer opportunities for remote work for Quality Engineers?

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.

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What tools and systems does the Quality Engineer at Tempus utilize?

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.

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What makes working as a Quality Engineer at Tempus unique?

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.

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Common Interview Questions for Quality Engineer
Can you explain your experience with quality assurance in the medical device industry?

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.

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How do you handle changes in project scope or requirements?

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.

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Describe a time you identified a significant quality issue. What steps did you take?

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.

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What methods do you use for risk management in product development?

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.

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How do you ensure compliance with international regulations?

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.

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What strategies do you employ for effective documentation?

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.

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How do you approach audits, both internal and external?

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.

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Can you provide an example of how you use data to drive quality improvements?

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.

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What is your experience with root cause analysis?

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.

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How do you prioritize tasks in a fast-paced environment?

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.

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MATCH
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FUNDING
SENIORITY LEVEL REQUIREMENT
TEAM SIZE
No info
SALARY RANGE
$70,000/yr - $90,000/yr
EMPLOYMENT TYPE
Full-time, on-site
DATE POSTED
December 12, 2024

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