Principal Quality Engineer
Core
Ensuring quality of controls, products, and processes in a medical device manufacturing environment through systematic monitoring, verification, and improvement to guarantee stability and compliance.
Role type
Principal Quality Engineer (Medical Devices)
Builds
Medical device products and manufacturing processes
Domain
Medical Devices / Advanced Wound Care / Ostomy Care / Infusion Care
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Manufacturing Quality Engineering, Process Validation, Computer System Validation, Risk Management (pFMEA, HA), Project Management, Team Supervision, Data Analysis, Change Control Management, Lean/Six Sigma
Preferred skills
Six Sigma Certification (Green/Black Belt), ISO 13485/14971 training, Engineering degree
Technologies
Lean, Six Sigma, Statistical analysis software
Responsibilities
Supervise Quality Engineers team, Plan and administrate Quality Assurance tasks, Support complaints investigations and root cause analysis, Ensure compliance of Site Master Validation Plan, Lead CAPA events, Support site Audit processes
Seniority
Principal, hands-on IC with mentorship