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

The Senior Product 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. This role 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. This role plans and executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.
This role requires onsite work in our Plymouth, Minnesota location with up to 10% domestic travel to other STERIS locations or to visit supplier sites as required.

• 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.
• Uses 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.
• Supervise Quality Engineers and other Quality staff in the execution of their assigned duties and objectives.
• Maintain product integrity and quality through the evaluation and disposition of nonconforming materials and processes.