Quality Engineer II

Position Summary The Quality Engineer II our Mentor, OH location 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 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 This position requires working onsite in our Mentor, OH location on a four 9- hour days and a 4-hour day schedule to support production. You can work either Monday to Thursday 7:00 am to 4:30pm, and Fridays 7:00am 11:00am Or Monday to Thursday 8:00am to 5:30 and Fridays 8:30 am to 12:00 pm. What You'll do as a Quality Engineer II - 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 trend analysis. - Initiate and/or participate in process and product corrective actions and problem-solving activities. - Update/establish documented work instructions as needed. - Review collected data to perform statistical analysis and recommend process/product changes to improve quality. - Monitor and report on performance metrics. - Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques. - Collaborate with other departments and facilities within the company on quality related issues. - 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 The Experience, Skills and Abilities Needed Required: - Bachelors' degree in Engineering - Minimum 3 years' combined Manufacturing/Quality Engineering and/or Quality Systems experience. - Minimum 3 years' experience working in an ISO certified environment required. Preferred: - Experience with medical device or other regulated industries preferred. - ASQ- Certified Quality Auditor and/or Quality Engineer, QMSR or familiarity with QMSR/GMP regulations preferred. - Proficiency with MS Office applications such as Excel, Word, PowerPoint. Other: - Excellent problem-solving skills - Has a continuous improvement mindset embracing new ideas and ways to think about a project. - Maintains strong relationships cross functionally to solve problems collaboratively. - Communicates through facts and data. - Demonstrates the technical aspects of the role. - Applies new technical tools and concepts under the direction of others. - Invests in growth through formal training or stretch project. - Completes assigned tasks on time by following standard work processes. - Thrives on change and adapts to leader-initiated changes. - Participates in change initiatives to better understand business and project goals. What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future. Here is just a brief overview of what we offer: Market Competitive pay Extensive Paid Time Off and added Holidays Excellent Healthcare, Dental and Vision benefits Long- and