Senior Software Quality Engineer

About the Role

The Senior Design Quality Engineer serves as a quality partner within the core product development team, driving design quality, risk management, and compliance throughout the product lifecycle. This role is distinct from software development and software testing and focuses on design controls, risk management, and quality systems. The candidate will collaborate cross-functionally with R&D software development and test, Regulatory, Marketing, Medical Safety, and Post-Market Quality to integrate quality principles and risk management into product development and implement strategies that enable continuous improvement. This is a Hybrid role based in Northridge, CA.

Responsibilities

• Engage as a quality core team member responsible for driving quality into the design and development of digital health solutions including medical mobile device applications (iOS/Android), web applications, cloud technologies (AWS/IBM Watson), data reports, and AI/ML solutions
• Drive the collaborative quality strategy for projects in alignment with business goals for cross-functional teams including R&D, Regulatory, Marketing, and Operations
• Drive quality oversight and evaluation of software systems activities within the software development lifecycle (Agile/Waterfall/DevOps) across requirements, design, development, documentation, integration, test, verification and validation
• Participate in design reviews and review and approve design input/design output artifacts including requirements, design documents, test results, verification and validation reports, and defects
• Ensure project and process control documentation comply with procedural requirements, applicable standards and regulations, with full requirement traceability maintained
• Lead and conduct risk management activities including system risk analysis and software FMEAs
• Manage and triage software issues with the cross-functional teams
• Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures
• Develop overall operating criteria to ensure implementation of the software quality program according to project, process, requirements and objectives
• Lead and drive CAPA (Corrective and Preventative Action) projects
• Drive quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures
• Participate in both internal and external regulatory audits and inspections
• Participate in and support Quality Management System reviews of Standard Operating Procedures aligned with US and international standards
• Support post-market team for FCAs or HRAs as needed

Qualifications

Must Have: Minimum Requirements

• Bachelor's Degree in Engineering, Science, or Technical Field with 4+ years of relevant experience in Quality, Engineering, and/or Software Development OR Advanced Degree in Engineering, Science, or Technical Field with 2+ years of relevant experience in Quality, Engineering, and/or Software Development
• Must have working knowledge of medical device compliance standards including IEC 62304, 13485, 14971, and FDA QMSR
• Ability to author technical reports, business correspondence, and standard operating procedures

Nice to Have

• Experience in software design and development, verification, validation, and testing activities for mobile application development and/or web applications and cloud infrastructure services (Amazon AWS/Microsoft Azure)
• Experience executing in the SDLC environment leveraging ALM tools (e.g., PTC Integrity/Atlassian Suite/TFS), defect tracking tools (e.g., Jira/PTC)
• Exposure to wireless communication protocols (e.g., Bluetooth)
• Working knowledge of integrated digital health systems including consumer products such as Apple/Android products
• CQE or CSQE Certification preferred