Senior Quality Engineer (Hybrid)

STERIS•Cleveland, OH

14h•$88,000 - $115,000•Hybrid

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 in our Mentor, Ohio Corporate 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. 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 Hybrid position requires that you reside within a reasonable commute to our Mentor, OH location. The hours for this role are Monday through Friday 8am to 5pm working onsite Monday, Tuesday and Thursday, and working from home Wednesday and Friday.

Requirements

Bachelor’s Degree Engineering.
Minimum of 6 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
Minimum of 6 years of experience working in an ISO certified environment required.
Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
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.

Nice To Haves

Minimum of 6 years of experience with medical device or other regulated industries preferred.
Certifications with ASQ, QSR or familiarity with QSR/GMP regulations preferred.
Experience with statistical analysis software and Visio preferred.
Experience with computer software validation and process validation.
Experience New Product Development (NPD) in a regulated environment.
Project Management experience, preferred.

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.
Perform all other duties as assigned