Quality Validation Engineer
Core
Creating and maintaining validation documentation for new and existing systems, processes, equipment, facilities, and software used in the manufacture, control, and storage of medical devices.
Role type
Quality Validation Engineer
Builds
Validated manufacturing systems and processes for diabetes care products (blood glucose test strips and sensors)
Domain
Medical Devices / Diabetes Care Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
validation lifecycle documentation, risk management, FDA 21 CFR Part 820, ISO 13485, design controls, design transfer, audit support, compliance monitoring
Preferred skills
site start-up support, new product introductions, technology transfers, greenfield projects
Technologies
None explicitly listed
Responsibilities
Develop, review, execute, and maintain validation protocols, reports, risk assessments, and plans; Ensure compliance with quality system requirements and regulatory standards; Collaborate with Quality, Engineering, Manufacturing, and Operations teams; Support internal, customer, and regulatory audits; Track and communicate validation metrics and compliance trends
Seniority
Mid-level, hands-on IC
