Sr. Software Quality Engineer
EPM Scientific
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. #J-18808-Ljbffr
Vacancy posted 8 hours ago
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