Sr. Software Quality Engineer

EPM Scientific; San Diego (CA); On-site; USD 100,000 - 130,000; Full time

Job summary

A MedTech innovator in San Diego is seeking a Senior Software Quality Engineer to join their expanding Quality team. The candidate will be responsible for leading software quality planning, bridging the gap between technical teams and quality functions, and implementing scalable quality systems. A background in IEC 62304 and experience within a Software as a Medical Device environment are essential for success in this role. The company offers significant growth potential as they continue to transform care through their innovative solutions.

Qualifications

• Working experience with IEC 62304 is required.
• Experience writing and creating processes is required.
• Experience in working in a Software as a Medical Device environment is essential.
• Demonstrated process validation experience (IQ, OQ, PQ) is necessary.
• Senior-level software quality engineering expertise with strong SDLC fluency is expected.
• Familiarity with modern test practices and tooling is crucial.
• Comfort operating in a regulated quality environment, preferably in MedTech.

Responsibilities

• Lead software quality planning and risk-based verification/validation.
• Build scalable quality systems and enable automation.
• Engage in problem-solving beyond standard SOPs.
• Develop new processes and procedures.
• Bridge the gap between quality and software.

Skills

IEC 62304

Process creation

Software as a Medical Device (SaMD)

Process validation (IQ, OQ, PQ)

Software quality engineering

Automation mindset

CI/CD integration

Data-driven quality

Job description

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.