Software Design Quality Assurance Engineer - Hybrid

Staff 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.

The Staff Software Design Quality Assurance Engineer is a leader that thinks “outside the box” in driving quality strategy and best-in‑class software development lifecycle practices at Caris Life Sciences. This individual will work closely alongside Software Quality Leadership, engineering, and other cross‑functional partners to ensure quality in software products through compliance with internal design, development and maintenance processes in combination with external applicable regulations and industry best practices.

This role must have leadership, coaching, and cross‑functional influence experience. The ideal candidate will have a blend of deep technical expertise, solid experience in risk management and compliance, and a passion for quality and improving patient outcomes. This role will be the subject‑matter expert for software development of medical device and computerized systems.

• Authors (as needed) and ensures quality records are produced during software development, verification, validation, and maintenance activities for SiMD and SaMD products are in accordance with internal SOPs, Quality System Requirements which include ISO 13485, FDA QSR, IVDR, SOX, SOC2, and IEC 62304.
• Reviews and approves various Design History File documents related to the software, including requirements, design, development, architecture and integration, test protocols, verification, validation, trace matrix, risk management (including cybersecurity), and configuration management.
• Supports the authoring and reviewing of pre‑defined deliverables as identified in the Computer System Validation Process and applicable Software Validation Planning documents in alignment with FDA QSR, 21 CFR Part 11, and GAMP5 regulation requirements.
• Collaborates with regulatory partners as a software quality subject‑matter expert to support regulatory submissions.
• Suggests design or test methods to achieve exceptional levels of product reliability, security, and quality.
• Leads the cross‑functional product development teams in performing risk assessments, defect assessments (FMEA), and cybersecurity risk analysis.
• Able to work independently with minimal supervision with objectives given by Sr. Software Quality Engineering Director. Also able to work with reporting software quality leader to support long‑term software quality strategy for software medical products and computerized systems products.
• Able to provide technical leadership and mentorship to software quality engineering peers.
• Serves as the designated backup to the Sr. Software Quality Engineering Director, assuming leadership responsibilities during the leader’s absence to ensure operational continuity and decision‑making coverage.
• 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.
• Leads process improvement initiatives as necessary, performing gap analysis and risk communication.
• Software Quality SME for internal, external, and regulatory audits.
• Performs complaint…