Staff Software Design Quality Assurance Engineer - Hybrid

Caris Life Sciences•Royal Oak, MI

14d•Hybrid

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. 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 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 quality the subject matter expert for software development of medical device and computerized systems.

Requirements

Bachelor’s degree in an engineering, scientific or related field with minimum 8+ years of relevant hands-on experience, or relevant comparable background.
Project experience (preferably 5-7 years of experience) in software validation practices, methodologies, and techniques, preferably in validating medical devices.
Experience in successfully leading new product development project teams through the design controls and risk management process, including all requirements and documents.
Strong knowledge of SDLC process and the application of ISO 13485, FDA QSR, 21 CFR Part 11, IEC 62304, GAMP5, SOX, and SOC2 requirements.
The ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate written and oral findings.
Experience with agile SDLC tools such as Atlassian (JIRA, Confluence and various plug-ins) or GitHub.
Solid knowledge of agile/scrum SDLC methodology.
Experience in successfully leading new software development teams through the software validation and risk management processes, including producing validation quality records.
Experience in leading, coaching and mentoring software quality engineering peers.
Must possess communication, negotiation skills, and the ability to influence and guide team members.
Experience in supporting internal, external, regulatory inspections.
Adaptable to fast-paced, dynamic work environment with shifting demands.
Must have the ability to manage multiple tasks simultaneously with thoroughness.
Communication – Proficient verbal and written communication skills.
Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results.
Teamwork – Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team.

Nice To Haves

Software development experience.
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 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 investigations, root cause analysis, CAPA, closure of audit/inspection observations, and other QMS activities related to software design controls and risk management.
Can plan and coordinate own work according to higher-level project schedule demands.
Executes quality, and compliance activities within required timelines, ensuring documentation, validation, and other software release artifacts are completed on schedule.