Quality Operations Engineer Shift
Core
Analyze quality standards for components, materials, or services in a manufacturing environment to ensure compliant product delivery.
Role type
Operations Quality Engineer
Builds
FreeStyle blood glucose test strips and FreeStyle Sensors for diabetes management
Domain
Healthcare / Medical Devices / Diabetes Care
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
quality principles application, inspection and verification, validation of processes and systems, FMEA management, CAPA program maintenance, risk management tools, change control support, calibration activities
Preferred skills
Yellow belt qualification
Technologies
GMP, GDP, ISO 13485
Responsibilities
Apply quality principles and analyze quality records to recommend improvements; Conduct inspection, verification, and validation of components or materials; Identify and address recurring problems with product quality or testing reliability; Document quality issues and performance measures for management review; Monitor and maintain the validation status of site products, processes, and systems; Investigate customer complaints and maintain Corrective and Preventive Action programs; Support DMR change control and calibration activities.
Seniority
Mid-level, hands-on IC
