QRC Group
Overview
Caguas, Puerto Rico | Posted on 09/26/2025 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. Responsibilities
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) Requirements
Bachelor’s in Engineering (Mechanical, Biomedical, Chemical, or Industrial) Technical Skills
IQ/OQ/PQ protocol development and execution FAT/SAT testing and documentation Injection molding and automated assembly validation Metrology equipment calibration and Gage R&R Experience with KNEAT software (highly desirable) Regulatory Knowledge
FDA21 CFR Part 820 EUMDR 2017/745 ISO13485 & ISO 14971 GMP compliance Certifications
ISO13485 Quality Management GMP Training Six Sigma (Green or Black Belt) Soft Skills
Strong documentation and report writing Ability to train personnel Analytical thinking and problem-solving
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Caguas, Puerto Rico | Posted on 09/26/2025 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. Responsibilities
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) Requirements
Bachelor’s in Engineering (Mechanical, Biomedical, Chemical, or Industrial) Technical Skills
IQ/OQ/PQ protocol development and execution FAT/SAT testing and documentation Injection molding and automated assembly validation Metrology equipment calibration and Gage R&R Experience with KNEAT software (highly desirable) Regulatory Knowledge
FDA21 CFR Part 820 EUMDR 2017/745 ISO13485 & ISO 14971 GMP compliance Certifications
ISO13485 Quality Management GMP Training Six Sigma (Green or Black Belt) Soft Skills
Strong documentation and report writing Ability to train personnel Analytical thinking and problem-solving
#J-18808-Ljbffr