Senior Quality Engineer - Software Design Controls

As a Senior Quality Engineer - Software Design Controls at Tempus, your key responsibilities will include supporting SDLC activities for medical device software and SaMD, maintaining relevant QMS procedures, generating necessary documentation throughout the software development lifecycle, and applying risk-based approaches to compliance. You'll also oversee compliance to various QMS procedures, including risk management and internal audits.

To qualify for the Senior Quality Engineer - Software Design Controls position at Tempus, candidates should ideally hold a BA or B.S. in Computer Science, Biomedical Engineering, or a related discipline, alongside 5+ years of experience in a software quality role within the medical device or FDA-regulated industry. Understanding of regulations like FDA QSR and ISO 13485 is essential.

Tempus is committed to the growth of its employees, including Senior Quality Engineers. The organization encourages continuous learning through training opportunities, seminars, and workshops. Furthermore, you'll collaborate with experienced professionals within the QA team, gaining insights and best practices that will enhance your career trajectory.

Candidates for the Senior Quality Engineer - Software Design Controls role at Tempus should have experience with industry tools like Jira and Jama, as well as familiarity with Agile and Scrum methodologies. Understanding SDLC best practices is critical for success in this fast-paced environment.

The expected salary range for a Senior Quality Engineer - Software Design Controls at Tempus in Illinois is between $100,000 and $150,000 USD. Compensation may vary based on qualifications and experience, reflecting our commitment to attracting top talent in the industry.

In your response, highlight your previous roles where you were responsible for maintaining or improving quality management systems. Be specific about the regulations you adhered to, such as FDA QSR or ISO 13485, and mention any QMS procedures you were involved with.

When answering this question, describe the stages of the SDLC, emphasizing your hands-on experience in each phase, particularly as it relates to quality assurance. Discuss how you ensured compliance and quality at every stage.

Explain the methods you utilize to remain informed on regulatory updates, such as subscribing to industry newsletters, attending conferences, or participating in webinars. Share examples of how this knowledge has benefited your previous work.

Discuss your experience with risk management practices, particularly in identifying, analyzing, and mitigating risks associated with software development. Provide examples of how you have implemented these strategies effectively.

Share details about a specific project, outlining the challenges faced and the quality assurance measures you implemented to navigate them successfully. Highlight teamwork, communication, and proactive problem solving.

Mention specific tools you have experience with, such as Jira or Jama, and explain how you used them for documentation purposes. Include any best practices you followed for maintaining thorough and accurate records.

Describe your approach to resolving conflicts by emphasizing communication, transparency, and collaboration. Provide an example of a time when you successfully navigated a disagreement to achieve project goals.

Talk about your familiarity with Agile practices, highlighting any specific roles you've held within Agile teams. Address how you tailored quality assurance processes to complement an Agile workflow.

Illustrate your dedication to continuous improvement by mentioning specific techniques or methodologies you employed to streamline quality assurance processes, such as Lean or Six Sigma.

This is a great opportunity to express your enthusiasm for Tempus and the impact its work has on healthcare. Highlight your alignment with Tempus's mission and how your skills are a match for the role, ensuring to convey genuine interest.