Process Validatie Specialist
Core
Prepare, coordinate, execute, and document validation activities for production processes and equipment to ensure compliance with quality standards and regulations.
Role type
Process Validation Specialist (Medical Devices)
Builds
Validated production processes and equipment for cardiovascular surgical and anesthesiology devices
Domain
Medical devices / Cardiovascular surgery
Required skills
Process validation, Equipment qualification (IQ/OQ/PQ), Risk analysis and management, ISO 13485, EU MDR (2017/745), Statistical process analysis, Change control
Preferred skills
Statistical process capability, GMP principles
Technologies
ISO 13485, EU MDR, IQ/OQ/PQ
Responsibilities
Develop and maintain validation master plans, protocols, and reports; Execute process validations to demonstrate consistency; Coordinate equipment qualification; Collaborate with Production, R&D, and QA; Investigate deviations and contribute to root cause analysis; Assess changes for re-validation needs.
Seniority
Mid-level, hands-on IC