Senior Software Design Quality Assurance Engineer - Hybrid

Role 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 ensue 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).

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 ‚Äì 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‚Äôs software development and validation practices comply with Caris‚Äôs Computer System Validation Process.
• Lead the cross-functional product development teams in performing risk management activities such as FMEA and cybersecurity risk analysis.
• 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).

Required Qualifications

• Bachelor‚Äôs 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.

Preferred Qualifications

• 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.

Physical Demands

• Employee may be required to lift routine office supplies and use standard office equipment.
• Ability to sit for extended periods of time.
• Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment.
• Travel may be required up to 10% of the time.