Overview
Software Quality Engineer Jobs in Bellevue, WA at SPECTRAFORCE
Title: Software Quality Engineer
Company: SPECTRAFORCE
Location: Bellevue, WA
Job Title: Sr. Principal Software Quality Engineer
Location: Bellevue, WA (Hybrid)
Duration: 12 Months (Temp to Hire)
We are seeking a Sr. Principal Software Quality Engineer to provide technical and strategic oversight for medical device software (SaMD/SiMD), AI/ML algorithms, digital health products, and cloud-based systems. This role involves design control, risk management, software security, and regulatory compliance (ISO 13485, IEC 62304, 21 CFR 820, ISO 14971) while collaborating with cross-functional teams.
Must-Haves:
✔ 8+ years of Software Quality Engineering experience in medical devices
✔ Strong knowledge of ISO 13485, IEC 62304, ISO 14971, 21 CFR 820
✔ Experience with DHF, design controls, risk management (RMF), and V&V
✔ Hands-on experience with software security, sBOM, Agile, and DevOps
✔ Proficiency in statistical analysis, Minitab, and CAPA processes
✔ B.S./M.S. in Engineering (Biomedical, Software, Computer Science, etc.)
✔ Preferred: CQE, Six Sigma Black Belt, experience with cloud-based software & cybersecurity
Interested? Reach out for the full job description!
