Risk Management Engineer
Core
Monitor, maintain, and enhance risk controls by analyzing quality data and major quality events to ensure global risk control for medical devices, cosmetics, and OTC drugs.
Role type
Risk Management Engineer
Builds
Automated risk-based trending system and risk-based dashboards for real-time decision-making
Domain
Medical device manufacturing / Quality Management Systems (QMS)
Deliverable
production ML models | dashboards & analysis
Required skills
Data analysis, Data normalization, Risk control implementation, Project management, Data visualization, Stakeholder collaboration, Regulatory compliance knowledge
Preferred skills
Six Sigma certification, Master's degree in Chemistry/Biology/Biotechnology
Technologies
Tableau, Power BI, Qlik, ISO 14971
Responsibilities
Analyze and normalize multiple streams of data to gauge system health, Create frameworks for risk-based dashboards, Identify inefficiencies in the global quality management system, Develop project timelines and ensure deadlines are met, Collaborate with R&D and manufacturing teams to implement risk controls, Support FDA inspections and regulatory compliance
Seniority
Mid-level, hands-on IC