Sr. Software Quality Engineer
Role: Sr. Software Quality Engineer
Location: San Diego, CA (on-site)
Salary: $125,000 - $145,000
EPM is partnered with a high-growth MedTech innovator who's transforming care through software-driven surgical planning. Already being revenue-generating, and recently receiving $150M, they have strong momentum moving forward and are looking to scale rapidly. They are expanding their Quality team and are looking for a Senior Software Quality Engineer to join their team and help bridge the gap between the technical teams and Quality/Regulatory.
Job Responsibilities
- Lead software quality planning, risk-based verification/validation, and traceability from requirements to test evidence.
- Build scalable quality systems: automation enablement, CI/CD quality gates, metrics, and continuous improvement.
- Think and problem solve and not just follow SOPs
- Write new process and procedures
- Be able to bridge the gap between quality and software
Qualifications
- Working experience with IEC 62304 (Required)
- Experience writing and creating a process (Required)
- Experience in working in a Software as a Medical Device (SaMD) environment
- Working process validation (IQ, OQ, PQ) experience
- Senior-level software quality engineering experience with strong SDLC fluency.
- Modern test practices and tooling: automation mindset, CI/CD integration, and data-driven quality.
- Comfort operating in a regulated quality environment (MedTech strongly preferred), including documentation rigor and cross-functional communication.
Benefits
- Competitve compensation package
- Bonus
- Health, vision, dental
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