Quality & Regulatory Compliance Intern - Fall/Spring

The STERIS Quality & Regulatory Compliance team is seeking a part-time intern to assist with a variety of projects on team.  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 Program Info:

• Dates: Fall 2026 - Spring 2027 (potential to extend)
• Location: Mentor, OH
• Work Environment: Onsite
• Hours: Part-time (20 hours minimum per week)

What You'll Do as a Quality & Regulatory Compliance Intern

• 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.
• Responsible for investigating and managing complaints for potential reporting under the FDA Medical Device Reporting regulations and applicable international regulations, preparing draft complaint summaries and MDR/Vigilance reports for presentation to the Reportable Events Committee for review, and maintaining documentation in accordance with department policies, procedures, and work instructions.  

The Experience, Skills and Abilities Needed

Required:

• Currently enrolled in college with a major in Science, Engineering, Regulatory, Internal Audit, or general business core concentration.
• Sophomore year requirements must be completed before internship start.
• Proficient PC skills, including Microsoft Office applications.

Preferred:

• GPA of 3.0 or above.

Other:

• 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.