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Validation Engineer bei QRC Group, Inc

QRC Group, Inc · Smyrna, Vereinigte Staaten Von Amerika · Onsite

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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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