Qa Engineer • Senior

Who you are

You have a strong background in quality engineering, particularly in the context of software design controls for medical devices. With experience in quality management systems (QMS) and the software development life cycle (SDLC), you understand the importance of adhering to regulatory requirements such as FDA’s Quality System Regulation (QSR) and ISO 13485. You are adept at identifying improvement opportunities within QMS procedures and have a keen eye for detail when it comes to documentation and deliverables.

Your knowledge of the evolving regulatory landscape for Digital Health, Artificial Intelligence, and Machine Learning technologies allows you to incorporate best practices into Tempus’ SDLC processes. You are familiar with risk management methodologies, including FMEA, and understand the significance of cybersecurity in medical device software development. You thrive in a collaborative environment and are committed to maintaining high standards of quality and compliance.

Desirable

A Bachelor's degree or higher in Computer Science or a related field is preferred, along with a solid understanding of software engineering principles. Experience with medical device software and familiarity with the specific challenges of Software as a Medical Device (SaMD) will set you apart. You are proactive in seeking out training opportunities for yourself and your colleagues, ensuring that the team remains knowledgeable about the latest regulatory changes and industry standards.

What you'll do

In this role, you will support Tempus’ SDLC activities for medical device software, ensuring that all necessary documentation and deliverables are generated and maintained throughout the software lifecycle. You will be responsible for applying innovative, scalable, and risk-based approaches to meet compliance for novel technologies in a fast-paced, multi-project environment. Your role will involve maintaining relevant procedures within the QMS, conducting internal and external audits, and managing change control processes.

You will also play a key role in training team members on QMS activities and procedures, fostering a culture of quality and compliance within the organization. By collaborating with cross-functional teams, you will help identify and address potential risks, ensuring that all software products meet the highest standards of quality and safety. Your contributions will directly impact the success of Tempus’ mission to improve patient outcomes through innovative technology.

What we offer

Tempus offers a dynamic work environment where you can make a meaningful impact on healthcare technology. You will have the opportunity to work alongside talented professionals who are dedicated to advancing the field of medical devices. We provide competitive compensation and benefits, along with opportunities for professional growth and development. Join us in our mission to transform healthcare through data-driven insights and innovative solutions.