QRC Group, Inc
Job Description
Job Description Company Description
QRC 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 Description
Validation 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. Scope Includes: Validation of new molding and assembly units Qualification of ISO7 clean rooms Integration of metrology instruments and handling systems Execution of IQ/OQ/PQ protocols, FAT/SAT, and traceability documentation Collaboration on a comprehensive Validation Master Plan Location:
SouthEast, United States (Travel Required)
Qualifications
Requirements Bachelor’s in Engineering (Mechanical, Biomedical, Chemical, or Industrial) 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 compliance Certifications 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-solving
Additional Information
All your information will be kept confidential according to EEO guidelines.
Job Description Company Description
QRC 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 Description
Validation 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. Scope Includes: Validation of new molding and assembly units Qualification of ISO7 clean rooms Integration of metrology instruments and handling systems Execution of IQ/OQ/PQ protocols, FAT/SAT, and traceability documentation Collaboration on a comprehensive Validation Master Plan Location:
SouthEast, United States (Travel Required)
Qualifications
Requirements Bachelor’s in Engineering (Mechanical, Biomedical, Chemical, or Industrial) 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 compliance Certifications 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-solving
Additional Information
All your information will be kept confidential according to EEO guidelines.