Senior Software Quality Design 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 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 CSV/CSA quality subject matter expert 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.

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, 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.
• 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).

Qualifications

• Required: Bachelor‚Äôs degree in an engineering, scientific or related field with minimum 4+ years of relevant hands-on experience, or relevant comparable background.
• Required: Strong knowledge of SDLC process and the application of ISO 13485, FDA QSR, 21 CFR Part 11, and GAMP5 requirements. Ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate written and oral findings.
• Required: Experience with agile SDLC tools such as Atlassian (JIRA, Confluence and various plug-ins) or GitHub.
• Required: Solid knowledge of agile/scrum SDLC methodology and its implementation of CSV/CSA practices.
• Required: Adaptable to fast-paced, dynamic work environment with shifting demands. Must have the ability to manage multiple tasks simultaneously with thoroughness.
• Required: Communication ‚Äì 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.
• Required: Teamwork ‚Äì Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team.
• Preferred: Project experience (preferably 3+ years of experience) in software validation practices, methodologies, and techniques, preferably in validating medical devices.
• Preferred: Software development experience.
• Preferred: Experience in successfully leading new software development teams through the software validation and risk management processes, including producing validation quality records.
• Preferred: Experience in supporting internal, external, regulatory inspections.
• Preferred: Knowledge of regulations pertaining to CLIA/CAP/LDT labs, Companion Diagnostic (CDx) or NGS is a plus.
• Preferred: Working knowledge or familiarity with medical device software (IEC 62304) is a plus.

Education

• Bachelor‚Äôs degree in engineering, science, or related field required (4+ years of relevant experience acceptable in lieu of degree in some cases).

Additional Requirements

• Physical Demands: Employee may be required to lift routine office supplies and use standard office equipment. Ability to sit for extended periods. Travel may be required up to 10% of the time.
• Training: All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.
• Other: This position requires periodic travel and some evenings, weekends and/or holidays. Job may require after-hours response to emergency issues. Periodically scheduled on-call may require after-hours response for technical emergencies not explicitly related to assigned job responsibilities. At times may be required to work weekends/holidays.