Senior Quality Engineer

The Senior Quality Engineer in our Mentor, OH location 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. As a Senior Quality Engineer, you lead 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. In this role, you plan and execute 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.

• Serveas the Core Team Member on cross-functional new product/service development teams with focus on the execution of quality plans and design/service transfer.
• Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis in support of products and service improvements.
• Leadprocess and product corrective actions and problem-solving activities.
• Review the current quality system and recommend / implement improvements as needed.
• Usedata to perform statistical analysis and recommend process / product changes to improve product and service quality.
• Leadprojects focused on quality system, product quality and service quality improvements.
• Developanalyses and reporton the performance of the quality system.

• Leadand supportinternal and external quality system audits.
• Instructother STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
• Collaboratewith other departments and facilities within the company on quality related issues.
• SuperviseQuality Engineers and other Quality staff in the execution of their assigned duties and objectives.
• Maintainproduct 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.

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 Short-Term Disability coverage
• 401(k) with a company match
• Maternity and Paternity Leave
• Additional add- on benefits / discounts for programs such as Pet Insurance
• Tuition Reimbursement and continuing education programs
• Excellent opportunities for advancement in a stable long-term career

#LI-MO1

#LI-Onsite