Senior Quality Engineer at STERIS Corporation in Mentor, OH
At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. Position Summary As a result of internal promotions and career growth opportunites, STERIS is currently recruiting for a Senior Quality Engineer. You will be responsible for developing, maintaining and improving the quality system in accordance with the requirements of, as appropriate, the following standards:
IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820. 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. You will also plan and execute activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems. Duties Participate on cross-functional new product development teams with focus on the execution of quality plans and design transfer. Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis. Lead and/or participate in process and product corrective actions and problem-solving activities. Constantly review the current quality system and recommend / implement improvements as needed. Review collected data to perform statistical analysis and recommend process / product changes to improve quality. Lead projects focused on to quality system, product quality and service quality improvement. Report on the performance of the quality system. Participate in strategic planning and audits of internal and supplier quality systems. Participate/support external and internal quality system audits. 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. Supervise 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 all other duties as assigned. Required Experience Bachelor's Degree in Engineering or related technical field required. 6
years of combined Quality Engineering and/or Quality Systems experience. 6
years of experience with medical device or other regulated industries preferred. 6
years of experience working in an ISO certified environment required. ASQ, QSR or familiarity with QSR/GMP regulations preferred. 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. What STERIS Offers The opportunity to join a company that will invest in you for the long-term. STERIS couldn't be where it is today without our incredible people. That's why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid-time off, holidays, matching 401(k), annual merit, and incentive plans. Join us and help write our next chapter.
Salary Range:
$80K -- $100K
Minimum Qualification
Industrial Engineering, Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820. 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. You will also plan and execute activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems. Duties Participate on cross-functional new product development teams with focus on the execution of quality plans and design transfer. Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis. Lead and/or participate in process and product corrective actions and problem-solving activities. Constantly review the current quality system and recommend / implement improvements as needed. Review collected data to perform statistical analysis and recommend process / product changes to improve quality. Lead projects focused on to quality system, product quality and service quality improvement. Report on the performance of the quality system. Participate in strategic planning and audits of internal and supplier quality systems. Participate/support external and internal quality system audits. 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. Supervise 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 all other duties as assigned. Required Experience Bachelor's Degree in Engineering or related technical field required. 6
years of combined Quality Engineering and/or Quality Systems experience. 6
years of experience with medical device or other regulated industries preferred. 6
years of experience working in an ISO certified environment required. ASQ, QSR or familiarity with QSR/GMP regulations preferred. 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. What STERIS Offers The opportunity to join a company that will invest in you for the long-term. STERIS couldn't be where it is today without our incredible people. That's why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid-time off, holidays, matching 401(k), annual merit, and incentive plans. Join us and help write our next chapter.
Salary Range:
$80K -- $100K
Minimum Qualification
Industrial Engineering, Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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