QRC
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Company Description QRC Group, LLC is a firm dedicated to offering services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Visit 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
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)
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.
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Company Description QRC Group, LLC is a firm dedicated to offering services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Visit 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
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)
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.
#J-18808-Ljbffr