Validation Engineer
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
- 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
Location: SouthEast, United States (Travel Required)
Additional Information
All your information will be kept confidential according to EEO guidelines.
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