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Caris Life Sciences · 5 hours ago

Staff Software Design Quality Assurance Engineer - Hybrid

Irving, TX

Full-time

Hybrid

Lead/Staff

8+ years exp

Caris Life Sciences is a company dedicated to transforming cancer care and improving lives through precision medicine. The Staff Software Design Quality Assurance Engineer will lead quality strategy and ensure compliance with design, development, and maintenance processes for software products, particularly in the medical device domain.

Artificial Intelligence (AI)BiopharmaBiotechnologyHealth CareLife Science

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

Qualification

Software validation practicesRisk managementISO 13485FDA QSRAgile SDLC toolsAgile/scrum methodologyCommunication skillsTeamworkTechnical leadershipMentoringAdaptability

Required

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