Product Safety Engineer

hace 7 días

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

Qrc Group Llc is seeking a Product Safety Engineer to join our team. The successful candidate will be responsible for ensuring the highest standards of product safety and performance by evaluating and validating sterilization procedures.

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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