Posted on: June 26, 2022
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 Quality Engineer is responsible for maintaining and improving
the quality system in accordance with the requirements of, as
appropriate, the following standards: IS0 9001, ISO 13485, MDSAP,
FDA 21 CFR Part 820/211, EU MDR and other applicable standards .
This role supports complaint/CAPA investigations, supplier quality
improvement, operations production and process controls, and
product and service quality improvement with the use of statistical
techniques and other accepted quality principles. This role
executes activities concerned with the development, implementation,
maintenance, and continuous improvement of STERIS quality
* Participate on cross-functional new product development teams
with focus on product/ service quality and Quality System
* Develop and implement statistically valid sampling plans,
designed experiments, capability studies, SPC and trend
* Initiate and/or participate in process and product corrective
actions and problem-solving activities.
* Update/establish documented work instructions as needed.
* Review collected data to perform statistical analysis and
recommend process/product changes to improve quality.
* Monitor and report on performance metrics.
* 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 support of
evaluation and disposition of nonconforming materials.
* Perform quality system audits and provide guidance on corrective
* Bachelor's Degree in Engineering General or Other Technology
* 1-5 years of combined Manufacturing/Quality Engineering and/or
Quality Systems experience.
* 1-5 years of experience working in an ISO certified environment
* 1-5 years of experience with medical device or other regulated
* ASQ, QSR or familiarity with QSR/GMP regulations preferred.
STERIS is a leading provider of products and services that meet the
needs of growth areas within Healthcare: procedures, devices,
vaccines and biologics. We exist to fulfill our MISSION TO HELP OUR
CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B,
publicly traded (NYSE: STE) company with approximately 16,000
associates and Customers in more than 100 countries.
STERIS strives to be an Equal Opportunity Employer.
Keywords: Steris, Chicago , Quality Engineer, Engineering , Chicago, Illinois
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