Senior Quality Engineer

Steris Corporation•Coon Rapids, MN

53d•Onsite

About The Position

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 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 position requires that you work onsite in our Eden Prairie facility Monday through Friday during core business hours 7am to 4 pm or 8am to 5pm. Must be available for occasional early morning calls with team in Germany.

Requirements

Bachelor's Degree in Engineering.
Minimum of 5 years of related experience required. (Manufacturing/Quality Engineering and/or Quality Systems).
5+ years of experience working in an ISO certified environment.
Experience with medical device or other regulated industries.
Quality Management System Regulation (FDA) QMSR Certification or familiarity with QMSR/GMP regulations.
Ability to travel to local supplier sites up to 10%.

Nice To Haves

ASQ, Certification, preferred.
Knowledge of Track Wise, Windchill PLM, Grand Avenue or other similar systems.
Experience with supplier controls, supplier audits or supplier monitoring.
Knowledge of ISO 13485 regulations.

Responsibilities

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 supplier audits and corrective actions.
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.