Job Title:  Quality & Regulatory Compliance Intern

Req ID:  38735
Job Category:  Intern

Mentor, OH, US, 44060-1834


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 STERIS Quality & Regulatory Compliance team is seeking an intern.  This role will provide a foundation for applying what has been learned in the classroom environment to practical hands-on application in a corporate environment. The Quality & Regulatory Compliance Intern will have exposure to domestic and international regulations and standards, business processes to ensure adherence to applicable regulations and standards, and collaboration with STERIS corporate domestic and international staff, Customers, Approved/Notified Bodies, and U.S and foreign government agencies.  

This role is onsite in Mentor, Ohio with the opportunity for a hybrid work schedule. Internship is a full year opportunity beginning in Fall of 2023.


  • Develop knowledge of regulations and standards including, but not limited to:
    • 21 CFR Part 820 – Medical Device Quality System Regulations (QSR)
    • 21 CFR Part 803 – Medical Device Reporting
    • 21 CFR Part 806 – Medical Device Corrections and Removals
    • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMP)
    • 21 CFR Part 11 – Electronic Records, Electronic Signatures
    • ISO 13485 Medical devices – Quality management systems
    • ISO 9001 Quality management systems – Requirements
    • EN ISO 11135-1 – Sterilization of healthcare products – Ethylene Oxide
    • EN ISO 11137-1 – Sterilization of healthcare products – Radiation
    • ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
    • EU Medical Device Regulation
  • Responsible for assembling product and Customer data concerning product corrections, removals, and field upgrades, tracking of Customer notifications and Field Service repairs, and maintenance of correction documentation.
  • Support execution of the supplier quality program, including, qualifications and/or audits, routine monitoring, assessment meetings, action requests and as necessary, issue resolution.
  • Provide support to the Quality & Regulatory Compliance team with investigation and resolution to audit findings.
  • Track corrective action activities for external audit observations and obtain and review objective evidence as actions are completed in accordance with prescribed commitments.
  • Perform data analysis/trending as requested.

Required Experience

  • Currently enrolled in college with a major in Science, Engineering, Regulatory, Internal Audit, or general business core concentration with a minimum GPA of 3.0 and completed Sophomore year


  • Proficient PC skills, including Microsoft Office applications.
  • Self-starter that is highly organized.
  • Strong interpersonal skills – ability to work closely with people at all levels within the organization and facilitate the implementation of corrective action; able to work effectively and professionally with external people including Customers and government officials.
  • Ability to exercise judgment regarding which approaches are acceptable for meeting compliance requirements and to timely recognize and communicate significant compliance issues for resolution to Quality & Regulatory Compliance management.
  • Strong oral and written communication skills.
  • Ability to balance multiple high priority responsibilities on-time and effectively.
  • Ability to perform assigned tasks in a highly complex environment.



STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention.  WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 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:  38735
Job Category:  Intern

Mentor, OH, US, 44060-1834

Job Segment: Medical Device, Infection Control, Internal Audit, Patient Care, Quality Manager, Healthcare, Finance, Quality