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Job Title:  Associate Systems Validation Analyst

Req ID:  25407
Job Category:  Engineering

Mentor, OH, US, 44060


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

We are currently looking for a Software QA Analyst,to join our agile IoT team at our headquarters, in Mentor,OH. Software QA Analysts play an integral role in ensuring that STERIS' enterprise solutions are designed, tested, and maintained in compliance with Federal Regulations and international standards. Software QAAnalysts create FDA computer system validation deliverables including System Assessments, Risk Analysis, Validation Plans, User/Functional/Design Requirements, Test Plans and Test Scripts, and Validation SummaryReports. They assist with project deliveries, and the management of project priorities, scope, timelines and expectations. They author and review verification and testing deliverables. They are also responsible for leading design and review sessions with project teams, Quality, Regulatory, IT and other business partners. Software QA Analysts assist with the development of procedures to test new and existing systems, and partner with cross-functional teams in continuous improvement efforts.


Software QA Analysts act as consultants, providing guidance on best practices to deliver projectsthat require FDA software validation compliance. Successful individuals are adaptable and have big picturethinking. They build relationships across our global business, and work in a matrix environment.

Required Experience

  • Bachelor's degree in Computer Science, IT, or related field with 4+ years’ experience in Quality Assurance required
  • 4+ years' experience with defect/test management tools required (JIRA, Validator, and ALM)
  • 1+ years’ experience in Regulatory, Quality or related field preferred
  • Java and C# experience preferred. Experience writing automation scripts (Selenium) a plus
  • QA experience in a federally regulated environment desired. Working knowledge of FDA, ISO, GxPregulations and standards a huge plus.
  • SDLC experience
  • Strong interpersonal, communication and organization skills
  • Microsoft Office skills (Excel, Word, Project and PowerPoint)


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.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.

Req ID:  25407
Job Category:  Engineering

Mentor, OH, US, 44060

Nearest Major Market: Cleveland
Nearest Secondary Market: Akron

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