Quality Engineer

Company DescriptionQRC 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!Job DescriptionQuality 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. QualificationsBachelor’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. Additional InformationAll your information will be kept confidential according to EEO guidelines.