​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!