Staff Quality Assurance Engineer
Core
Own quality processes, guide cross-functional teams through quality management systems, and ensure product quality for customers in life sciences and diagnostics.
Role type
Staff Quality Assurance Engineer
Builds
Medical device instruments, laboratory instrumentation, diagnostic analyzers, and automation platforms
Domain
Life sciences, diagnostics, biotechnology, medical devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Engineering, Manufacturing Engineering, Quality Systems, ISO 9001, ISO 13485, 21 CFR Part 820, EU MDR/IVDR, process validation, equipment qualification, nonconformance management, CAPA, risk management, continuous improvement, data analytics, business intelligence
Preferred skills
Advanced Power BI, DAX development, Power Query, dashboard design, KPI development, Six Sigma, DMAIC, Statistical Process Control, 5 why's, 8D, PFMEA, Design of Experiment, Oracle ERP, IQVIA eQMS
Technologies
Power BI, Oracle, IQVIA
Responsibilities
Represent Quality Assurance on cross-functional teams for business critical initiatives, apply industry standards and regulations to internal policies, serve as local process owner for Production & Process Controls, coach teams on quality systems processes, leverage data analytics to identify trends and drive risk-based decision making
Seniority
Staff, hands-on IC with strategic guidance