Position Summary The Senior Quality Engineer is responsible for maintaining and improving the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, NOM-241-SSA1, ASME Sección VIII division 1 and other applicable standards. This role supports complaint/CAPA investigations, supplier quality improvement, operations production and process controls, and product and service quality improvement with the use of statistical techniques and other accepted quality principles. This role executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems. Duties
• Serves as the Core Team Member on cross-functional new product/service development teams with focus on the execution of quality plans and design/service transfer.
• Develops and implements statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis in support of products and service improvements.
• Leads process and product corrective actions and problem-solving activities.
• Reviews the current quality system and recommend / implement improvements as needed.
• Uses data to perform statistical analysis and recommend process / product changes to improve product and service quality.
• Leads projects focused on quality system, product quality and service quality improvements.
• Develops analyses and reports on the performance of the quality system.
• Leads supplier audits and corrective actions.
• Leads and supports internal and external quality system audits.




• Instructs other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
• Collaborates with other departments and facilities within the company on quality related issues.
• Supervises Quality Engineers and other Quality staff in the execution of their assigned duties and objectives.
• Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials.
• Perform quality system audits and provide guidance on corrective actions.
• Perform other duties as assigned
• Ensure established documentation / work instructions is properly updated as required
• Analysis and report on performance metrics as warranties, Installation Defects Per Unit, Out Of the Box (early) failures, Warranty Failures, In process Defects Per Unit, In Process First Pass Yield to lead the development of action plans to improve KPI’s of top issues
• Compliance FDA and ISO 13485
• Lead Quality Engineers in Non-destructive testing (NDT) according to CSEI (AQSIQ)
• ASME and PED code activities.
• Maintain and improve the quality system in accordance with the requirements, as appropriate, of the following standards: ISO 9001, ISO 13485,



MDSAP and FDA 21 CFR Part 820/211, EU MDR, NOM-241-SSA1, and other applicable standards. Education Degree
• Bachelor's Degree in Engineering General Required Experience +5 years:
• Combined Manufacturing/Quality Engineering/Quality Systems experience
• Working in an ISO certified environment required. Preferred Experience +5 years:
• Medical device or other regulated industries experience preferred.
• ASQ, QSR or familiarity with QSR/GMP regulations
• Demonstrate experience leading or participating on improvement projects
• Background on steel, mechanic assembly process
• Knowledge on problem solving methodologies Skills
• Excellent problem-solving skills
• Focus on identification of potential issues and continuous improvement.
• Experience working on cross-functional teams and on own initiative.
• Demonstrated excellent organizational, oral and written communications skills.
• Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
• Experience with statistical analysis software and Visio preferred. Working Conditions 10% Walking, 70% Sitting and 20% Standing STERIS is a leading general provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe. For more information, visit www.steris.com. STERIS strives to be an Equal Opportunity Employer.

📌 Senior Quality Engineer (Isla Guadalupe)
🏢 STERIS Mexico de C.V. (Operations
📍 Isla Guadalupe