Quality Engineer II - Process Validation
Core
Senior Quality Engineer supporting end-to-end process validation for medical device new product introductions and lifecycle management.
Role type
Senior IC Quality Engineer (Process Validation)
Builds
Medical devices ensuring regulatory compliance and product safety
Domain
Medical Devices / Regulatory Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation methodologies, statistical data analysis, root cause investigation, regulatory audit support, cross-functional collaboration, ISO 13485/FDA QSR/EU MDR compliance knowledge
Preferred skills
Plastic processing techniques (Extrusion, Injection Moulding, Blow Moulding), quality improvement tools
Technologies
ISO 13485, FDA QSR, EU MDR
Responsibilities
Oversee end-to-end validation activities for processes and equipment; author and review qualification/validation documentation; perform statistical analysis for product standards; support regulatory and internal audits; drive problem solving for quality issues; provide online support during design and validation builds
Seniority
Senior, hands-on IC
