Service & Delivery Quality Process Engineer
Core
Execute tactical quality activities and projects to support customer needs, radiology informatics strategy implementation, and business success for software as a medical device.
Role type
Quality Process Engineer (Software as a Medical Device)
Builds
Quality Management System processes, corrective/preventive actions, and risk management assessments for radiology informatics software.
Domain
Medical Device / Radiology Informatics / Software Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
QMS implementation, CAPA management, internal/external audit facilitation, risk management tools, regulatory standards translation, root cause analysis, software design assessment, market feedback analysis
Preferred skills
PMP certification, data analysis, multi-location project leadership
Technologies
Excel, PowerPoint, Word
Responsibilities
Facilitate QMS service activities across departments and sites, initiate and support process improvements, manage internal and external audits, advise on corrective and preventive actions, participate in QMS maintenance and transformation projects, apply risk management tools, translate regulations into QMS, verify QMS changes impacting service, perform software quality engineering tasks including design assessment and test review
Seniority
Mid-Senior, hands-on IC