Sr Quality Engineer.
Core
Ensures products and processes meet quality, regulatory, and business requirements in a regulated manufacturing environment.
Role type
Senior IC Quality Engineer (Medical Devices)
Builds
Production processes, inspection/testing mechanisms, and audit-ready documentation for medical devices.
Domain
Medical device manufacturing / Quality Assurance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality systems knowledge, manufacturing process experience, technical problem-solving, risk assessment, statistical analysis, CAPA management, change control, validation concepts, supplier quality management, structured problem-solving tools (5 Whys, Fishbone, FMEA), data analysis methods (SPC, DOE, capability analysis), hands-on tool usage (Minitab, JMP, Excel, SAP, JDE)
Preferred skills
Lean Six Sigma Green/Black Belt, automation/dashboards/data extraction, basic programming (VBA, Python), experience with FDA/ISO-regulated environments, NPI support, component qualification
Technologies
Minitab, JMP, Excel, Power BI, SAP, JDE, Factory Works, VBA, Python
Responsibilities
Develop and maintain quality standards and protocols for processing materials; collaborate with engineering and manufacturing to ensure quality standards; devise and implement methods for inspecting, testing, and evaluating product precision; design inspection/testing mechanisms and conduct QA tests; ensure corrective measures meet reliability standards and documentation compliance; support NPI, product transfers, and supplier qualification initiatives.
Seniority
Senior, hands-on IC
