Sr. Software Quality Engineer

EPM is partnered with a high-growth Med Tech 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.

• 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

• 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 (Med Tech strongly preferred), including documentation rigor and cross-functional communication.