Supplier Quality Engineer

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.

 

The Supplier Quality Engineer in our St. Louis, MO 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.  You will 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 will plan and execute activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

 

Day Shift:  Monday to Thursday (four 10-hour day schedule) with most Fridays off!  

What you’ll do as a Supplier Quality Engineer

 

• Serve 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. 
• Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis in support of products and service improvements. 
• Lead process and product corrective actions and problem-solving activities. 
• Review the current quality system and recommend / implement improvements as needed. 
• Use data to perform statistical analysis and recommend process / product changes to improve product and service quality.
• Lead projects focused on quality system, product quality and service quality improvements. 
• Develop analyses and reports on the performance of the quality system. 
• Lead supplier audits and corrective actions. 

• Lead and support internal and external 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. 
• Maintain product integrity and quality through the evaluation and disposition of nonconforming materials and processes.

The Experience, Skills and Abilities Needed:

 

Required:

 

• Bachelors’ degree in Engineering or related technical field. 
• Minimum 6 years’ combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• Minimum 6 years’ experience working in an ISO certified environment required.
• 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.
• Experience with MS Office applications including Excel, Word, and PowerPoint.

 

Preferred:

 

• Minimum 6 years’ experience with medical device or other regulated industries preferred.
• ASQ- Certified Quality Auditor and/or Quality Engineer, QSR or familiarity with QSR/GMP regulations preferred.
• Ex