Lead, Quality & Regulatory Compliance Auditor

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 mission of the STERIS Quality & Regulatory Compliance function is to implement repeatable and sustainable processes to ensure on-going compliance with domestic and international regulations and standards. This includes evaluating the relevance to all STERIS facilities and products and implementing efficient and effective processes to ensure adherence to applicable regulations and standards.

The compliance activities require close work with STERIS corporate domestic and international staff and Customers and U.S and foreign government agencies.

• This position is based in Mentor, OH 
• 20% domestic and international travel required

Duties

1. Responsible for conducting data analysis and identifying areas of compliance risk and vulnerability
2. Ensures compliance with regulations and controls by examining and analysing records, reports, operating practices, and documentation; recommends opportunities to strengthen the internal control structure
3. Responsible for reporting to Senior Management the results of data gathering, audit results, and process improvements implemented as a result of continuous monitoring program
4. Design, implement, and maintain audit programs to fulfil compliance audits
5. Will manage the schedule and execution of compliance audits
6. Responsible for reviewing procedures and conduct appropriate compliance audit examination
7. Will manage and approve completion of established remediation for identified areas of risk
8. Effectively manage and communicate the development of Compliance policies and procedures with strong working knowledge of policy development and approval process
9. Manage the outputs of the investigation and research of compliance issues
10. Research, interpret, and perform efficient gap analysis for new and updated regulations and standards
11. Responsible for leading and directing other staff in the performance of compliance audits at STERIS facilities as well as unscheduled audits as directed by Quality & Regulatory Compliance Senior Management
12. Lead the organizational staff by coaching, managing, motivating, monitoring, and evaluating them through ongoing performance feedback and formal reviews, as well as development initiatives which target individual strengths and weaknesses while delivering business results
13. Review test plans and validation documentation for IT systems
14. Assist in compliance projects as needed

Required Experience

• Four (4) year degree required, preferably with general business core, risk management, project management, regulatory, or internal audit
• Minimum of 2 years of regulatory compliance auditor 
• Minimum of 2 years of supervisory / people management experience 

Skills/ Knowledge Required

• Excellent PC skills, including Microsoft Office applications
• Experience working with and effectively leading cross-functional team
• Strong leadership skills including ability to lead and collaborate
• Demonstrated ability to motivate, train, and develop a high-performance team
• Ability to balance multiple high priority responsibilities on-time and effectively
• Can comfortably and effectively confront difficult situations and issues in a timely and appropriate manner
• Strong interpersonal skills – ability to work closely with people at all levels within the STERIS organization and facilitate the implementation of corrective action; able to work effectively and professionally with external people including Customers and government officials
• Strong oral and written communication skills

 

Additionally, the Lead, Quality and Regulatory Compliance Auditor must have expert working knowledge of 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 7 – Enforcement Policy, Subpart C – Recalls
• 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
• ISO 14971 Ap