Senior Software Quality Design Assurance Engineer - Hybrid

Caris Life Sciences-posted 1 day ago

Full-time • Senior

Hybrid • Royal Oak, MI

1,001-5,000 employees

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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 Senior Software Design Quality Assurance Engineer thinks “outside the box” in the implementation of the Software Design Control and SDLC (software development lifecycle) programs at Caris Life Sciences, providing quality oversight, and ensuring compliance with all applicable regulations and incorporations of software industry best practices. Guides software development project teams as a Computer Systems Validation (CSV) and Computer Software Assurance (CSA) quality subject matter expert and to ensure organizational processes are followed and industry best practices are incorporated throughout the software development process. The scope of CSV/CSA includes computerized systems and software tools (used to support software development, quality management systems, and production/process).

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, 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. This includes quality oversight on the following records that support the validation package (as applicable): Validation Plan, System Risk Assessment, User Requirements, Design Specifications, Verification and Validation Testing, Summary Report, and Trace Matrices.
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.
Able to work independently with minimal supervision with objectives given by Sr. Software Quality Director. Can plan and coordinate own work according to higher-level project schedule demands.
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.
As needed provide quality support for the development and maintenance of software in a medical device (SiMD), software as a medical device (SaMD),software used in lab developed tests (LDT).

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.
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 and its implementation of CSV/CSA practices.
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.

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.

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