Sterilization Process Expert

hace 7 días

Cidra, Puerto Rico Qrc Group Llc A tiempo completo
Job Overview

We are looking for a skilled Sterilization Process Expert to join our team at Qrc Group Llc. The successful candidate will be responsible for evaluating and validating sterilization procedures to ensure compliance with industry regulations and standards.

Key Responsibilities:

  • Collaborate closely with cross-functional teams to drive quality improvements and maintain high standards for product safety and performance.
  • Evaluate and validate sterilization procedures to guarantee compliance with industry regulations and standards.

Requirements:

  • A Bachelor's degree in Engineering (Biomedical, Chemical, Mechanical, or related field).
  • 3-5 years of experience in a quality engineering role, with a focus on sterilization processes, especially gamma radiation.
  • A strong understanding of sterilization principles, validation processes, and regulatory standards.
  • Experience with ISO 11137, ISO 13485, FDA regulations, and other relevant industry standards.
  • Proficiency with quality tools such as root cause analysis, failure mode effect analysis (FMEA), and statistical process control (SPC).
  • Experience with sterilization equipment and data analysis.

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