Senior Quality Engineer - Process Validation
Core
Lead end-to-end validation activities for medical devices to ensure processes, equipment, and products meet regulatory and quality standards throughout the product lifecycle.
Role type
Senior Quality Engineer (Process Validation)
Builds
Medical devices and production processes
Domain
Healthcare / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
IQ/OQ/PQ lifecycle management, risk management, statistical data analysis, root cause investigation, regulatory compliance (ISO 13485, FDA QSR, EU MDR), equipment qualification, test method validation
Preferred skills
Experience in highly regulated industries, mentorship of junior engineers, continuous improvement methodologies
Technologies
ISO 13485, FDA QSR, EU MDR
Responsibilities
Lead and oversee end-to-end validation activities; develop device process validation strategy; author and support qualification/validation plans and reports; devise and implement methods for inspecting and testing products; ensure validation activities align with regulatory requirements; support regulatory and internal audits; mentor junior engineers; support root cause investigations.
Seniority
Senior, hands-on IC
