Senior Software Design Quality Assurance Engineer - Hybrid

Caris Mpi • Irving, TX

83d

About The Position

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.

Requirements

• Bachelor's degree in an engineering, scientific or related field with minimum 4+ 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.

Nice To Haves

• Experience with agile SDLC tools such as Atlassian (JIRA, Confluence and various plug-ins) or GitLab.
• Project experience (preferably 3+ 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.
• Working knowledge or familiarity with medical device software (IEC 62304) is a plus.

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, IVDR, 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.
• Leads by example - 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.
• Participates in Supplier Qualification Audits of software suppliers that will be used to support the development of an Off-the-shelf (OTS) computerized system.
• Partner with a lead auditor to ensure the supplier's software development and validation practices comply with Caris's Computer System Validation Process.
• Lead the cross-functional product development teams in performing risk management activities such as FMEA and cybersecurity risk analysis.
• Develops and Maintains CSV/CSA SOPs, work instructions, and templates as necessary to support process improvements.
• Participates in process improvement initiatives as necessary, performing gap analysis and risk communication.
• Assists in internal, external, and regulatory inspection readiness activities and provide support during audits.
• Performs complaint investigations, root cause analysis, CAPA, closure of audit/inspection observations, and other QMS activities related to software design controls and risk management.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree