Quality Engineer II

The Quality Engineer is responsible for maintaining and improving the quality system in accordance with the requirements of, as appropriate, the following standards: ISO 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.

• Participate on cross-functional new product development teams with focus on product/ service quality and Quality System compliance.
• Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and t...