Systems Engineering Analyst

Caris MPI, Inc.; Phoenix (AZ); On-site; USD 60,000 - 90,000; Full time

Job summary

Caris Life Sciences seeks a qualified professional to ensure equipment compliance with regulatory requirements and GDP across asset lifecycles. Responsibilities include instrument requalification, report authoring, and audit support, with cross-functional collaboration across QA, IT, Lab, and Systems Engineering.

The role requires a degree in engineering or sciences, knowledge of CAP/CLIA/ISO 13485/21 CFR Part 820, and experience in a regulated lab environment; Lean Six Sigma is a plus.

Qualifications

• Knowledge of quality systems requirements per CAP/CLIA, ISO 13485 and 21 CFR Part 820.
• GDP data/document handling and record-keeping
• Experience in regulated laboratory environments (1–2 years preferred)
• MS Office Suite proficiency (Word, Excel, Outlook)

Responsibilities

• Ensure equipment verification records comply with regulatory requirements (CLIA, NYS, CAP, ISO, FDA, IVDR).
• Collaborate on requalification of instrumentation to maintain compliance and efficiency.
• Author/review cross-correlation reports for molecular, IHC and liquid profiling workflows.
• Support SOP creation, review, and implementation; manage company records per regulatory policies.
• Participate in internal/external audits and provide required documentation.

Skills

QMS knowledge

GDP adherence

Regulatory compliance

MS Office proficiency

Education

Bachelor's degree (engineering, biological science, computer science, or similar)

Master's degree (engineering, biological science, computer science, or similar)

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 SummaryThis 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 ResponsibilitiesEnsure 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 QualificationsBachelor's degree in engineering, biological science, computer science, or similar fieldStrong 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 QualificationsLean 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 DemandsEmployee 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.TrainingAll job specific, safety, and compliance training are assigned based on the job functions associated with this employee.OtherThis 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.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.