Quality Engineering Lead
Core
Lead statistical process control, root cause investigations, and continuous improvement initiatives to ensure quality and compliance of medical devices throughout their lifecycle.
Role type
Senior IC Quality Engineering Lead
Builds
Medical devices and manufacturing processes
Domain
Medical Device / Pharmaceutical Industry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical Process Control (SPC), Lean Six Sigma (DMAIC), root cause analysis, CAPA, risk management, validation activities, regulatory compliance, data-driven problem solving
Preferred skills
Mentorship, cross-functional partnership, audit presentation
Technologies
ISO13485, SPC tools, DMAIC, 8D
Responsibilities
Lead SPC and process capability initiatives, drive root cause investigations and CAPA activities, provide oversight for product/process changes and validation, partner with cross-functional teams on quality risks, serve as technical expert during audits and investigations, mentor Quality Engineers
Seniority
Senior, hands-on IC with management responsibilities