Quality Engineering Technician

Overview Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at www.cretexmedical.com. Position Summary: Cretex Medical is seeking a Quality Engineering Technician to oversee the operations of our production and cleanroom environments. This role is pivotal in ensuring compliance with cleanroom standards and maintaining the calibration of equipment to uphold product quality and regulatory requirements. The successful candidate will conduct environmental monitoring, manage equipment calibration, perform inspections, and support continuous improvement initiatives. Responsibilities Environmental Monitoring, Testing, and Reporting Conduct monthly environmental monitoring (particulate and microbial testing) in Class 7 and Class 8 cleanrooms. Coordinate with external labs for testing and compile environmental reports, analyzing data to identify trends and implementing corrective actions as needed. Complete all activities for the environmental monitoring program to ensure regulatory compliance. Validation, Documentation, and Calibration Assist engineers in validation and verification activities, supporting compliance and process integrity. Update and maintain cleanroom and calibration documentation, ensuring audit readiness. Perform sterilization and cleaning tests, supporting study requirements, routine radiation dose audits, and EO re-qualification. Monitor, inspect, set up, calibrate, and maintain manufacturing and cleanroom equipment, managing calibration schedules and coordinating with outside calibration services as needed. Process Audits and Quality Improvement Conduct process audits to verify adherence to 5S standards and quality protocols. Participate in root cause analysis and corrective actions to resolve non-conformances and support CAPA and customer complaint processes. Support continuous improvement initiatives to enhance cleanroom practices, equipment reliability, and quality-related processes. Training, Compliance, and Technical Skills Provide training and guidance to staff on cleanroom protocols, equipment usage, and calibration procedures. Apply blueprint reading and GD&T knowledge to support inspection and process quality. Ensure documentation and activities comply with ISO standards and regulatory requirements, maintaining an audit-ready state. Qualifications Job Requirements: Associate degree in Engineering, Biology/Microbiology, or a related technical field. 2-5 years in a quality role within a regulated environment, preferably in medical device manufacturing or cleanroom operations. Proficiency in cleanroom standards (ISO Class 7 and Class 8) and environmental monitoring techniques. Experience with equipment calibration and maintenance, including managing calibration…