Senior Quality Engineer - Software Design Controls

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.

We are looking for a Senior Quality Engineer (Software Design Controls) who will be

involved in quality management system (QMS) and software development life cycle

(SDLC) activities, in accordance with FDA’s Quality System Regulation (QSR), ISO 13485, and other applicable regulatory requirements, as well as best practices in the software industry. This position is within the Tempus Quality Assurance (QA) group.

Responsibilities

● Support Tempus’ SDLC activities for medical device software and Software as a Medical

Device (SaMD).

● Support Tempus’ QMS activities by maintaining relevant procedures, identifying improvement opportunities, and providing training

● Ensure required documentation and DHF deliverables are generated and maintained

throughout SDLC of medical device software/SaMD, including SRS, SAD, SDS, V&V,

traceability, risk management/FMEA, and cybersecurity.

● Apply innovative, scalable and risk-based approaches to meeting compliance for novel

technologies in a fast-paced, multi-project environment.

● Maintain knowledge of the evolving regulatory landscape for Digital Health, Artificial

Intelligence and Machine Learning technologies, and incorporate best practices in

Tempus’ SDLC processes and QMS.

● Support compliance to various QMS procedures and activities including but not limited

to: risk management, CAPAs, complaint/defect root-cause investigations, internal and

external audits, management reviews, change control, training.

● Performs other related duties and responsibilities as assigned.

Preferred Qualifications

● BA/B.S. or higher preferred in Computer Science, Software Engineering, Biomedical, or relevant engineering disciplines.

● 5+ years in a software quality (design assurance/controls) role in the medical device/IVD

(or FDA regulated) industry.

● Experience and working knowledge of applicable regulations and standards: FDA QSR,

ISO 13485, IEC 62304, ISO 14971

● Expertise in SDLC best practices, and experience with industry tools such as Atlassian (Jira) and Jama.

● Experience with Agile/Scrum/iterative software development methodology.

● Excellent organizational, interpersonal, verbal and written communication skills

● Ability to deliver quality outputs under minimal supervision.

Illinois Pay Range - $100,000 - $150,000 USD

The expected salary range above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, 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.