Gamma Radiation Specialist

The Qrc Group Llc is looking for a Gamma Radiation Specialist to join our team. As a key member of our Quality Engineering group, you will be responsible for ensuring that our products meet the highest standards of quality and safety.

• Develop and implement gamma radiation sterilization processes to ensure compliance with industry standards and regulatory 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.

• 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.

This is an exciting opportunity for someone who is passionate about quality and safety to join our team and contribute to the development of innovative medical devices.