Software Quality Assurance Engineer
Job description
THIS IS NOT A SOFTWARE VALIDATION OR TESTING ROLE. Must have experience working with software development teams.
We are looking for a Software Quality Engineer for one of our more established medical device clients in San Deigo. This is a hybrid role that is 2x/week onsite. They will be a part of core design and development teams.
Key Responsibilities:
Act as a Quality liaison within project teams, guiding quality measures throughout the software development lifecycle and overseeing quality-related documentation.
Integrate quality practices into software development, scientific computation, and data acquisition processes.
Evaluate and approve software project deliverables, ensuring compliance with procedural standards.
Conduct risk assessments, manage risk mitigation activities, document product risks, and liaise with the risk management team for updates.
Maintain adherence to company's quality processes in software development and risk management efforts.
Required Qualifications:
Preference for familiarity with mobile, embedded software, or web-based technologies.
Proficient understanding of FDA and international regulations, including QSRs, ISO 14971, IEC 62304.
Over 2 years of experience in software Quality Assurance within the medical devices sector or other FDA-regulated industries, covering the full product lifecycle from conceptual design to market release.
Experience managing the Design Control process, including participation in design reviews and the maintenance of design history files.
The compensation for this role is 80k-104k + bonus + equity. Apply for more details!