Operations Quality 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
Manufacturing of diabetes care products (blood glucose test strips and sensors)
Domain
Healthcare manufacturing / Medical Devices
Required skills
Quality principles, sampling methods, testing methodology, GMP, GDP, ISO 13485, FMEA, CAPA, risk management tools, validation planning
Preferred skills
Yellow belt qualification
Technologies
None stated
Responsibilities
Apply quality principles and analyze quality records; Conduct inspection and validation of components; Identify and address recurring quality or reliability problems; Document quality issues and performance measures; Monitor and maintain validation status of products, processes, and systems; Investigate customer complaints and maintain Corrective and Preventive Action programs; Report metrics and identify trends; Support equipment, software, and process validation activities; Maintain compliance of quality records.
Seniority
Mid-level (3 years experience required)