Senior Software Quality Engineer
About The Position
The Senior Software Quality Engineer is part of the core new product development team and drives software quality activities for regulated digital health solutions, including iOS and Android mobile applications, web applications, cloud-based data-driven solutions, reports, and AI/ML solutions. The role applies software development lifecycle processes—including Waterfall, Agile, and DevOps—in the regulated medical device industry. It is a hybrid position based in Northridge, California. The position provides quality oversight across software lifecycle activities, maintains compliance with applicable procedures, standards, and regulations, and collaborates with cross-functional teams. It also leads risk management, defect management, CAPA and quality improvement work, supports audits and post-market activities, and develops software quality processes and operating criteria.
Requirements
- Bachelor's degree in Engineering, Science, or a technical field and at least 4 years of relevant experience in Quality, Engineering, and/or Software Development; or an advanced degree in one of these fields and at least 2 years of relevant experience.
- Working knowledge of medical device compliance standards, including IEC 62304, ISO 13485, ISO 14971, and FDA QMSR.
- Ability to author technical reports, business correspondence, and standard operating procedures.
Nice To Haves
- Experience with software design and development, verification, validation, and testing for mobile applications, web applications, and/or cloud infrastructure services such as Amazon AWS or Microsoft Azure.
- Experience working in an SDLC environment using ALM tools such as PTC Integrity, Atlassian Suite, or TFS, and defect tracking tools such as Jira or PTC.
- Exposure to wireless communication protocols such as Bluetooth.
- Working knowledge of integrated digital health systems, including consumer products such as Apple and Android products.
- CQE or CSQE certification.
Responsibilities
- Serve as a quality core team member and drive quality into the design and development of digital health solutions, collaborating with R&D, Regulatory, Marketing, and Operations.
- Develop collaborative quality strategies for projects in alignment with business goals.
- Provide quality oversight and evaluate software lifecycle activities across requirements, design, development, documentation, integration, testing, verification, and validation.
- Participate in design reviews and review and approve design inputs and outputs, including requirements, design documents, test results, verification and validation reports, and defects.
- Ensure project and process control documentation complies with procedural requirements, applicable standards, and regulations, with full requirements traceability maintained.
- Lead and conduct risk management activities, including system risk analysis and software FMEAs.
- Manage and triage software issues with cross-functional teams.
- Develop, modify, apply, and maintain standards, methods, processes, and procedures for software systems quality.
- Develop operating criteria to ensure implementation of the software quality program according to project, process, requirements, and objectives.
- Lead and drive CAPA projects and quality improvement projects, including compliance standards for software quality methods, processes, and procedures.
- Participate in internal and external regulatory audits and inspections.
- Participate in and support Quality Management System reviews of Standard Operating Procedures aligned with U.S. and international standards.
- Support the post-market team for FCAs or HRAs as needed.
Benefits
- Competitive salary and flexible benefits package.
- Health insurance.
- Dental insurance.
- Vision insurance.
- Health Savings Account access.
- Healthcare Flexible Spending Account access.
- Life insurance.
- Long-term disability leave.
- Dependent daycare spending account.
- Incentive plans, including eligibility for a Short Term Incentive (STI).
- 401(k) plan with company match.
- Short-term disability coverage.
- Paid time off and holidays.
- Employee Stock Purchase Plan participation.
- Employee Assistance Program access.
- Eligible employees may have access to a Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
