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Job Title:  QA Analyst

Req ID:  15866
Job Category:  Regulatory Affairs
Country/Region:  US
State:  OH
Zip:  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.

What You Will Do

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 QA Analysts create FDA computer system validation deliverables including: System Assessments, Risk Analysis, Validation Plans, User/Functional/Design Requirements, Test Plans and Test Scripts and Validation Summary Reports.  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 crossfunctional teams in continuous improvement efforts.


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

What You Need To Be Successful
  • 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, GxP regulations and standards a huge plus.
  • SDLC experience
  • Strong interpersonal, communication and organization skills
  • Microsoft Office skills (Excel, Word, Project and PowerPoint)



Offering You In Return

The opportunity to join a company that will invest in you for the long-term. STERIS wouldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid-time off, holidays, matching 401(k), annual merit, and incentive plans.  Join us and help write our next chapter.


STERIS is a $2B+, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates 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.

Nearest Major Market: Cleveland
Nearest Secondary Market: Akron

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