Senior Sterilization Process Engineer

hace 7 días

Cidra, Puerto Rico Qrc Group Llc A tiempo completo
Senior Sterilization Process Engineer

We are seeking a skilled Senior Sterilization Process Engineer with expertise in gamma radiation sterilization. The ideal candidate will have hands-on experience in developing, implementing, and validating sterilization processes to ensure compliance with industry standards and regulatory requirements.

Responsibilities:
  • Develop, implement, and validate sterilization processes, focusing on gamma radiation sterilization.
  • Ensure compliance with regulatory standards such as ISO 11137, ISO 13485, and FDA requirements.
  • Collaborate with cross-functional teams to define sterilization protocols and procedures for new product development.
  • Conduct performance qualification (PQ), installation qualification (IQ), and operational qualification (OQ) testing for sterilization equipment.
Requirements:
  • 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.
  • Strong understanding of sterilization principles, validation processes, and regulatory standards.
  • Experience with ISO 11137, ISO 13485, FDA regulations, and other industry standards related to sterilization.
  • Proficiency with quality tools such as root cause analysis, failure mode effect analysis (FMEA), and statistical process control (SPC).
  • Experience with sterilization equipment (gamma irradiators, biological indicators, etc.) and data analysis.

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