QRC
Company Overview
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 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. Location
SouthEast, United States (Travel Required) 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 Qualifications
Bachelor’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 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. Seniority level
Executive Employment type
Contract Job function
Quality Assurance Industries
Technology, Information and Internet
#J-18808-Ljbffr
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 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. Location
SouthEast, United States (Travel Required) 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 Qualifications
Bachelor’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 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. Seniority level
Executive Employment type
Contract Job function
Quality Assurance Industries
Technology, Information and Internet
#J-18808-Ljbffr