*Role Validation Engineer - Medical Devices*
Duration: 9+ Months
Location: PA, CO, NY , FL
Skill Tag Black Box Testing, CSV, ISO 13485
*Overall Responsibilities: *
Project Quality Support in the CSV Equipment Legacy Review
Project Quality Support in CSV Equipment Remediation Projects
v Cover the part of the GxP-Compliance in the project.
v Creation of the Validation documentation for GxP relevant system
v Know and follow the guidelines regarding the code of conduct, ethics and
compliance programs and other relevant regulations
v Planning, coordination, execution and reporting of activities related to
the project Requirements:
v Higher education (Engineer or similar) and background in IT
v Experience in similar position or extended experience as executer
v Knowledge of national and international regulations and standards
v GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFR, Part 820, Part 11
v CSV Experience in the area of Medical Devices Manufacturing
v Team Player
v Excellent Communication skills
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