Senior Quality Engineer

The Senior Quality Engineer is responsible for managing processes and leading projects to maintain and improve the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820/211, EU MDR and other applicable standards. The Senior Quality Engineer leads complaint/CAPA investigations, supplier quality improvement actions, operations production and process control improvements, and product and service quality improvements with the use of statistical techniques and other accepted quality principles. The Senior Quality Engineer plans and executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

This role will work in close collaboration with the Production and Quality Control teams.

• 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 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.
• Maintains product integrity and quality through the evaluation and disposition of nonconforming materials and processes.
• Perform all other duties as assigned.

• 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 working in an ISO certified environment required.
• 6+ years of experience with medical device or other regulated industries including experience with biological products strongly 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
• ASQ, QSR or familiarity with QSR/GMP regulations preferred.
• Experience with statistical analysis software and Visio preferred.

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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