Systems Engineering Analyst

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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.

This position is responsible for equipment compliance with all applicable regulatory requirements. This role ensures adherence to Good Documentation Practices (GDP) in all paper and electronic records generated within asset lifecycle management for all managed equipment and assets. This includes assisting with the authoring and review of instrument reports, facilitation of corrections per GDP, ensuring data integrity across laboratory instrumentation records in applicable electronic platforms, and performing final quality signoff for work orders and verifications.

Job Responsibilities

• Ensure equipment verification record compliance with all applicable regulatory requirements (CLIA, NYS, CAP, ISO, FDA, IVDR, etc.).
• Collaborate and assist in clinical requalification of instrumentation to maintain company-wide regulatory compliance and operational efficiency.
• Author cross-correlation reports for Molecular, IHC and liquid profiling workflows.
• Ensure requalification paperwork is reviewed and approved in a timely fashion.
• Review records for accuracy and Good Documentation Practices (GDP).
• Analyze system / process dependencies between laboratory instrumentation, operations, IT infrastructure, and Quality to define and execute projects within the validation programs.
• Participate in internal and external audits with tasks such as audit preparation, answering questions, and providing documentation to auditors.
• Support asset lifecycle management activities.
• Author, review, revise, and implement standard operating procedures (SOPs).
• Manage company records in accordance with regulatory requirements and company policies.
• Engage in cross-functional collaborations between Systems Engineering, Laboratory, IT, Software QA, and Quality teams to support program alignment between organizational and regulatory requirements.

Required Qualifications

Preferred Qualifications

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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.

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