Sr. Software Quality Engineer

Quality Core Team Member

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), cloud technologies (AWS/IBM Watson), data reports, and AI/ML.

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-focused design and development of software within the software development lifecycle (Agile, Waterfall, SAFe, DevOps) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability.

Participate in design reviews for the system as well as review and approve design input/design output artifacts including requirements, design documents, code review, test results, verification and validation reports, and defects.

Lead and conduct risk management activities including system risk analysis and software FMEA's.

Lead and drive CAPA (Corrective and Preventative Action) projects.

Participate in both internal and external regulatory audits and inspections.

Drive quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures (such as ISO13485, IEC62304, HIPAA, FDA, Security Standards, Data Privacy).

Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.

Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation.

Defines appropriate measures to ensure product quality.

Develops overall operating criteria to ensure implementation of the software quality program according to project, process, and contract requirements and objectives.

Ensures that projects and process control documentation are compliant with requirements, objectives, and/or contracts.

Join our team in Northridge, CA, where innovation meets quality in the heart of the tech industry. Experience a vibrant community and enjoy an excellent work-life balance while contributing to groundbreaking digital health solutions.

EEO Employer

LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.