Sr. Quality Engineer - Nogales
Core
Lead quality engineering and validation for medical device manufacturing, ensuring compliance with FDA/GMP/ISO standards and managing corrective actions for product quality.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Validated manufacturing processes and compliant medical device products
Domain
Medical Devices / Consumer Health
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Industrial Engineering, FDA/GMP/ISO-13485 regulations, Statistical Process Control (SPC), Validation (IQ/OQ/PQ), Root Cause Analysis (RCA), People Leadership
Preferred skills
Minitab, PPK, Hypothesis Testing, 5 Whys, Ishikawa diagrams
Technologies
Minitab
Responsibilities
Review and approve validation protocols for equipment and processes; Lead the quality engineering group to ensure compliance with validation requirements; Coordinate material and process inspection methods; Analyze statistics to monitor non-conforming products; Lead improvement projects for plant processes; Provide training to quality department personnel.
Seniority
Senior, hands-on IC with leadership