Quality Engineer - job 1 of 2

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!

Quality Engineer with a strong background in sterilization processes, specifically gamma radiation. Have hands-on experience in the validation, testing, and monitoring of sterilization procedures, with a focus on ensuring compliance with industry standards and regulatory requirements. This role involves working closely with cross-functional teams to drive quality improvements and maintain high standards for product safety and performance.

Responsibilities: 

• Develop, implement, and validate sterilization processes, with a primary focus 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.
• Perform risk assessments and manage sterilization validation projects from design to execution.
• Conduct performance qualification (PQ), installation qualification (IQ), and operational qualification (OQ) testing for sterilization equipment.
• Analyze sterilization data, perform trending, and generate reports to identify areas for improvement.
• Investigate and resolve non-conformances and deviations related to sterilization processes.
• Provide support during internal and external audits, ensuring proper documentation and compliance with regulatory guidelines.
• Monitor sterilization process parameters and provide continuous improvement recommendations.

• 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.

All your information will be kept confidential according to EEO guidelines.