Senior Software Quality Engineer - SaMD, CI/CD & Regulatory

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

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.