Job Title:  Quality & Regulatory Compliance Intern - Summer 2025

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.  

Key Internship Information:

• Dates: Summer 2025 program - May-August
• Office location: Mentor, OH
• Work environment: Hybrid

Duties

• 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.

Experience + Skills

• Currently enrolled in college majoring in Science, Engineering, Regulatory, Internal Audit, or general business core concentration. Minimum GPA of 3.0 and completed Sophomore year by start of internship.
• 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.