Software Design Quality Assurance Engineer - Hybrid

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives.

We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: “What would I do if this patient were my mom?” That question drives everything we do.

But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare—driven by innovation, compassion, and purpose.

Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.

Position Summary

The Software Design Quality Assurance Engineer is responsible for ensuring computerized software/systems used in support of the Quality Management System are developed, validated, and maintained in compliance with applicable regulatory standards.  Collaborate with software development project teams as a Computer Systems Validation (CSV) and Computer Software Assurance (CSA) quality subject matter expert to ensure organizational processes are followed and industry best practices are incorporated throughout the software development process. The scope of CSV/CSA includes computerized systems and software tools (used to support software development, quality management systems, and production/process).

Job Responsibilities

• Authors (as needed) and ensures quality records produced during software development, validation, maintenance activities are in accordance with Quality System Requirements which include ISO 13485, FDA QSR, 21 CFR Part 11, and GAMP5 requirements.

• Supports the authoring and reviewing of pre-defined deliverables as identified in the Computer System Validation Process and applicable Software Validation Planning documents.  The ability to author (as needed) and ensure quality records produced during software validation process are accurate, clear, concise, and sufficient for multiple projects at a time.  This includes quality oversight on the following records that support the validation package (as applicable): Validation Plan, System Risk Assessment, User Requirements, Design Specifications, Verification and Validation Testing, Summary Report, and Trace Matrices. 

• Can plan and coordinate own work according to higher-level project schedule demands. 

• Participates in process improvement initiatives as necessary.  Supports the maintenance of CSV/CSA SOPs, work instructions, and templates as necessary to support process improvements.

Required Qualifications

• Bachelor’s degree in an engineering, scientific or related field with minimum 2+ years of relevant hands-on experience, or relevant comparable background.

• Strong knowledge of SDLC process and the application of ISO 13485, FDA QSR, 21 CFR Part 11, and GAMP5 requirements.

• Solid knowledge of agile/scrum SDLC methodology and its implementation of CSV/CSA practices.

• Adaptable to fast-paced, dynamic work environment with shifting demands.

Preferred Qualifications

• Experience with agile SDLC tools such as Atlassian (JIRA, Confluence and various plug-ins) or GitLab.

• Project experience (preferably 1-2 years of experience) in software validation practices, methodologies, and techniques, preferably in validating medical devices.

• Software development experience.

• Experience in successfully leading new software development teams through the software validation and risk management processes, including producing validation quality records.

• Experience in supporting internal, external, regulatory inspections.

• Knowledge of regulations pertaining to CLIA/CAP/LDT labs, Companion Diagnostic (CDx) or NGS (Next Gen Sequencing) is a plus.

Physical Demands

• Employee may be required to lift routine office supplies and use standard office equipment.

• Ability to sit for extended periods of time.

• Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment.

• Travel may be required up to 10% of the time.

Training

• All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

Other

• This position requires periodic travel and some evenings, weekends and/or holidays.

• Job may require after-hours response to emergency issues.

• Periodically scheduled on-call may require after-hours response for technical emergencies not explicitly related to assigned job responsibilities.

• At times may be required to work weekends/holidays.

Conditions of Employment:  Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.

This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.