Validation Engineer

Company DescriptionQRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!Job DescriptionValidation Engineers to support the internal development and validation of a multi-dose preservative-free (MDPF) nozzle subsystem and any other miscellaneous project related deliverables as they arise.Location: SouthEast, United States (Travel Required)Scope Includes:Validation of new molding and assembly unitsQualification of ISO7 clean roomsIntegration of metrology instruments and handling systemsExecution of IQ/OQ/PQ protocols, FAT/SAT, and traceability documentationCollaboration on a comprehensive Validation Master PlanQualificationsBachelor’s in Engineering (Mechanical, Biomedical, Chemical, or Industrial)Location: SouthEast, United States (Travel Required)Technical Skills IQ/OQ/PQ protocol development and execution FAT/SAT testing and documentation Validation Master Plan (VMP) creation MES/SCADA system qualification Injection molding and automated assembly validation Metrology equipment calibration and Gage R&R Traceability Matrix development Experience with KNEAT software (highly desirable)Regulatory Knowledge FDA 21 CFR Part 820 EU MDR 2017/745 ISO 13485 & ISO 14971 GMP complianceCertifications ISO 13485 Quality Management ISO 14971 Risk Management GMP Training Six Sigma (Green or Black Belt)Soft Skills Strong documentation and report writing Cross-functional collaboration Ability to train personnel Analytical thinking and problem-solvingAdditional InformationAll your information will be kept confidential according to EEO guidelines.