Staff Software Quality Engineer, Post Market Integration
Core
Lead quality engineering for commercialized medical devices, driving complex investigations, risk management, and regulatory compliance to ensure patient safety and product reliability.
Role type
Staff Software Quality Engineer (Post Market Integration)
Builds
Commercialized endoscopy and communications products
Domain
Medical Devices / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, Risk management, CAPA, Change management, Statistical methodologies, Quality system expertise, SDLC processes, Regulatory compliance, Cross-functional leadership
Preferred skills
Medical device industry experience, ISO 13485, GDP, GMP, Computer hardware knowledge
Technologies
None explicitly stated
Responsibilities
Lead customer complaint investigations and nonconformance reviews; Drive corrective actions and product improvements; Partner with R&D and operations to address quality issues; Analyze quality metrics to identify trends; Support internal and external audits and regulatory inspections; Mentor technical teams
Seniority
Staff, hands-on IC with strategic leadership
