Senior Software Quality Engineer
Core
Senior quality partner ensuring software products meet company requirements, regulations, and industry standards throughout the SDLC.
Role type
Senior Software Quality Engineer (Regulated Industry)
Builds
Software products for genomic technology and health equity
Domain
Biotechnology / Genomics / Healthcare
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Software quality engineering, SDLC processes, risk management, regulatory compliance (IEC 62304, ISO 13485, 21 CFR), cross-functional collaboration, audit support, CAPA management, cloud platform quality, AI-enabled solution quality
Preferred skills
Mentoring junior engineers, global delivery model experience, Quality/Regulatory certifications (ASQ, AAMI, RAPS)
Technologies
Cloud-based platforms, AI-enabled capabilities
Responsibilities
Support software quality activities throughout SDLC and PDP, serve as primary quality representative on cross-functional teams, review and approve lifecycle deliverables (requirements, design, test docs, cybersecurity, risk records), partner with Dev, Program Management, Regulatory Affairs, and Security teams, provide guidance on quality processes and system requirements, participate in design reviews, support complaint investigations and corrective actions, identify process improvement opportunities, support internal/external audits, deliver training on quality best practices, escalate quality risks.
Seniority
Senior, hands-on IC with mentorship responsibilities