Quality & Regulatory Compliance Intern
The STERIS Quality & Regulatory Compliance team is seeking an intern. Ideally, the individual could start working part-time as soon as possible, full-time in the summer, and potentially continue in the fall - but we are open to Summer only applicants as well. 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, Notified Bodies, and U.S and foreign government agencies.
What You Will Do:
- Develop knowledge with the following regulations and standards
- 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 13485:2016 Medical devices – Quality management systems
- ISO 9001:2015 Quality management systems – Requirements
- EN ISO 11135-1:2007 – Sterilization of healthcare products – Ethylene Oxide
- EN ISO 11137-1:2006 – Sterilization of healthcare products – Radiation
- ISO/IEC 17025:2017 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.
What You Will Need to be Successful:
- Currently enrolled in college with a major in Science, Engineering, Regulatory, Internal Audit, or general business core concentration.
- Minimum GPA of 3.0
- Bilingual skills are a plus, but not required.
- 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.
Offering you in Return:
An opportunity to gain corporate experience in compliance at a large global healthcare company to supplement your education.