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 Quality Engineer (Hybrid) in our Mentor OH location 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. The Quality Engineer 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 systems. 

 

Experience working with a Quality Management System (QMS)

Experience in an ISO 13485 environment is strongly preferred. 

Experience with Data Analytics, preferred.   

What you will do as a Quality Engineer:

 

• Participate on cross-functional new product development teams with focus on product/ service quality and Quality System compliance. 
• Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis. 
• 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. 

The Experience, Skills and Abilities Needed:

Required: 

• Bachelor’s Degree (Engineering or related technical field), required. 
• Minimum of 1 year of combined Manufacturing/Quality Engineering/Quality Systems (QMS) experience or minimum of 6 months on-site STERIS internship or co-op experience.
• Minimum of 1 year of 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.
• Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.

 

Preferred:

• Experience with ISO13485 strongly preferred.   
• Strong experience with Quality Management Systems (QMS), preferred.
• Experience with statistical analysis software and Visio preferred.
• Experience with Data Analytics, preferred. 
• Experience with electronic QMS systems such as Trackwise, Master Control, SAP, Oracle, or Veeva, preferred. 
• Minimum of 1 year of experience with medical device or other regulated industries preferred.
• ASQ, QSR or familiarity with QSR/GMP regulations preferred.

What STERIS Offers:

 

We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future