Direct message the job poster from BVI Medical BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe. Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors. Our trusted brands include Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Sin.-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses). Purpose: This position is responsible for supporting the Quality Manager in managing the quality management system, compliance to regulations related to all quality control inspections, validation and approval of sterilization processes. Support to engineering projects, R & D projects and process transfer Responsible for monitoring, auditing or reviewing sterilization processes and external testing laboratories as well as associated procedures. Carry out support activities during production movements in controlled rooms. Solve the problems presented in some cycle of the sterilizer and communicate to the staff the risks and actions for the solution of the problem. Prepare and / or review / approve validation protocols and reports, FMEA's, risk analysis, standard operating procedures, inspection and manufacturing procedures, list of materials, routing, inspection plans, drawings, and purchase specifications. Support operational activities / QA, such as handling complaints, disposal of non-conforming material, corrective and preventive actions, internal and external audits Develop, implement, and maintain sterilization validation protocols (e.g., ETO, gamma) in accordance with ISO 11135, ISO 11137, and related standards. Serve as the key point-person, subject matter expert for all things related to Sterilization. Ensure compliance with ISO 13485, Support routine sterilization dose audits, sterilization validation, and applicable global regulations. Proactively lead essential project management for Sterilization—overseeing test sample configuration, writing protocols, facilitating sample logistics, tracking test results, and writing reports. Collaborate with external labs to execute tests, interpret results, and author comprehensive reports that drive product safety and compliance. Partner with R&D, Regulatory, and Manufacturing to integrate quality requirements (sterilization) into key new products changes and critical sustaining changes. Support internal/external audits and regulatory inspections. Lead CAPA investigations and drive continuous improvement initiatives. Review sterilization run records in a frequently basis and release product Requirements: Strong understanding of sterilization methods and their scientific principles. Must have a deep knowledge of proven techniques to solve problems such as lean, DOE, statistical analysis, 8D, TQM methods, Six Sigma methodology. Demonstrate ability to support and direct teams and cross training of other associates. 5 or more years of experience in the profession of Quality Assurance or 3 years of experience with FDA QSR, and compliance with ISO13485. related position; Knowledge of the manufacturing process. a Bachelor's degree in science or engineering master's degree in sciences El Paso, TX $88,500.00-$127,200.00 3 weeks ago #J-18808-Ljbffr