Description and details of activities 1\. Coordinates and performs environmental monitoring activities, including interpretation of results. 2\. Prepares and coordinates routine samples for endotoxin testing, including interpretation of results. 3\. Prepares and coordinates routine biological load testing, including interpretation of results and trend analysis of test outcomes. 4\. Performs sterilization load release activities and investigates load non-conformances. 5\. Coordinates and leads requalification of sterilization loads and dose audits. 6\. Initiates and investigates internal/external non-conformances and is responsible for ensuring completion of all phases. 7\. Generates Engineering Change Notifications (ECNs) to update Quality System documentation such as procedures, drawings, BOM/routers, labor standards, test methods, and/or inspection criteria. 8\. Maintains communication with contracted sterilizers and laboratories. 9\. Supports and leads internal and external audits. 10\. Performs other duties and tasks as required. ESSENTIAL PHYSICAL/ENVIRONMENTAL REQUIREMENTS \- Lifting \- Up to 50 lbs. * Writing * Sitting * Standing * Bending * Visual acuity * Color perception * Depth perception * Reading * Peripheral/visual field Experience and requirements MINIMUM QUALIFICATIONS SUMMARY * High school equivalent education with six years of related work experience, or equivalent. * Strong analytical skills and ability to solve moderately complex technical problems. * Excellent organizational and interpersonal skills. * Demonstrated computer knowledge, preferably spreadsheets, word processing, databases, and other applicable software programs. * Ability to work effectively as a team member. * Knowledge of various test tools and equipment. * Experience in test sample preparation, equipment setup and operation, test data recording and analysis. * Experience in extraction, processing, and reporting of engineering data. COMPETENCIES * Communication skills. * Interpersonal skills. * Organizational skills. * Teamwork. * Problem solving. COMMENTS Infection Control Risk Category III: Risk category explains whether employees are likely or not to come into contact with blood or bodily fluids while performing their job. Risk Category III indicates jobs and procedures that do not require exposure. Benefits * Benefits according to the Federal Labor Law Apply directly through our portal APPLY **Number of vacancies** 1 **Area** Quality **Contract** Permanent **Modality** On-site **Shift** Daytime **Workload** Full-time **Education** Technical degree **Travel availability** No