Senior Quality Engineer - Mentor, OH, US,

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 opportunities STERIS is currently recr ...

Job description

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 opportunities 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.

What You Will Do:

• 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.

What You Need To Be Successful:

• 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.

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Our Healthcare Customers are federally mandated (by Center for Medicare & Medicaid Services or CMS) requiring vendors to have the COVID-19 vaccination or an approved exemption. There are select Customers who do not accept any exceptions. Unvaccinated Associates may be excluded from working at a Customer site, require routine testing with an approved exemption (if accepted by the Customer) or have limited Customer access impacting their ability to remain employed. Additionally, we may be required to meet state mandates on COVID-19 vaccination, exemptions and/or booster requirements. This position is a Customer-facing role that falls under a state or CMS mandate.

STERIS is a leading global 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, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.

If you need assistance completing the application process, please call This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location's HR Office during normal business hours.