Systems Engineering Analyst

Caris Life Sciences; Phoenix (AZ); On-site; USD 90,000 - 130,000; Full time

Job summary

Caris Life Sciences is seeking a regulatory/compliance professional to ensure equipment records meet GDP, CLIA, CAP, ISO 13485, and FDA standards within the asset lifecycle. You will author and review instrument reports, support requalification, and ensure data integrity across laboratory instrumentation records.

Collaborating with Systems, IT, and Quality teams, you will participate in audits, implement SOPs, and manage documentation to maintain regulatory compliance and operational efficiency.

Qualifications

• Bachelor's degree in engineering, biological sciences, computer science, or similar field.
• Strong knowledge of QMS requirements per CAP/CLIA, ISO 13485, and 21 CFR Part 820.
• One year of experience working in a regulated laboratory environment.
• Proficient in Microsoft Office Suite (Word, Excel, Outlook) and general internet usage for business.

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.

Skills

QMS knowledge

Regulatory compliance

Documentation

Education

Bachelor's degree in engineering/biological sciences

Master's degree preferred

Tools

Excel

Word

Outlook

Job description

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

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

• Bachelor's degree in engineering, biological science, computer science, or similar field
• Strong knowledge of QMS requirements per CAP/CLIA, ISO 13485, and 21 CFR Part 820.
• One year of experience working in a regulated laboratory environment.
• Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use.

Preferred Qualifications

• Lean Six Sigma certified.
• Two years of experience working in a regulated laboratory environment with a focus on laboratory instrumentation and equipment.
• Master's degree in engineering, biological science, computer science, or similar field.

Physical Demands

• Employee must be able to use standard office equipment.
• Employee must have ability to sit and stand for extended periods of time.
• Work is split between desk/cubicle environment and laboratory environment.
• Employee may have exposure to high noise levels, fumes, and biohazardous materials in the laboratory environment.

Training

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

Other

This position requires some evenings, weekends and/or 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.

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.