Senior Software Quality Engineer
Core
Senior Software Quality Engineer ensuring product software compliance with regulatory requirements (21 CFR 820, QMSR, ISO 13485, IEC 62304) and driving quality activities for assigned programs. (via careerplan.io/jobs/42967-JOB-senior-software-quality-engineer-at-illumina)
Role type
Senior Software Quality Engineer (Regulated Industry)
Builds
Software quality deliverables, verification/validation plans, risk management activities, and audit support for medical device software.
Domain
MedTech / Genomics / Regulated Software
Required skills
Software Quality Engineering, SDLC processes, Regulatory compliance (21 CFR 820, ISO 13485, IEC 62304), Risk management, Test protocol design, Requirement traceability, Design review, CAPA investigation, Audit support
Preferred skills
Mentoring junior engineers, Cross-functional collaboration in global delivery models, New technology adoption (AI/ML, Cloud), Quality certifications (ASQ, AAMI, RAPS)
Technologies
AI/ML, Cloud, Cybersecurity tools
Responsibilities
Serve as SME in Software Quality Engineering, Review and approve development deliverables (plans, requirements, design docs), Drive software risk management activities, Support internal and external audits, Assist in developing training on quality processes, Escalate risks proactively
Seniority
Senior, hands-on IC with mentorship responsibilities