Lead, Quality & Regulatory Compliance Auditor

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.

• This is a hybrid role based in STERIS' Corporate Offices in Mentor, Ohio. In order to support the business needs working a minimum of 3 days a week in the Mentor office is expected.
• 20% domestic and international travel required

• Lead internal quality audits to assess compliance of a facility's quality management system with applicable US and international standards, regulatory requirements, and Corporate and local procedures, policies, and work instructions. Conduct internal audits using good time management practices to maximize efficiency.
• Draft internal audit reports to clearly communicate audit findings and recommendations for compliance improvements.
• Address and resolve any differences in viewpoints in a positive manner with a focus on continuous improvement and business efficiency while maintaining compliance.
• Train developing auditors to support the internal quality auditing activity.
• Support execution of the supplier quality audit 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 in the investigation and resolution of audit observations
• Review corrective action activities for audit observations and obtain and review objective evidence as actions
• are completed in accordance with prescribed commitments.
• Lead and support the Quality Operations team in supporting key objectives, trending, and process
• improvement.

Required:

• Four (4) year degree required, preferably with general business core, risk management, project management, regulatory, or internal audit
• Minimum of four (4) yearsprofessional experience,preferably includingregulatory affairs, legal,governmental compliance,quality systems, or internalauditing.
• 25% travel required (domestic & international).

Preferred:

• Leadership / people management experience preferred.
• Experience in themedical device industry isa plus.
• Professional certifications and regulatory training certificates in relevant disciplines are desirable, as is completion of or actively working towards an advanced degree in a relevant discipline.
• Bilingual skills are a plus, but not required.

Skills:

• Provide support to Quality & Regulatory Compliance department management asrequested during the development of Senior Management and ComplianceCommittee presentation materials or special projects.
• Conduct yourself in accordance with the principles of the STERIS Code ofBusiness Conduct and comply with all Company policies.
• Protect company confidential information by properly storing, retrieving, anddisseminating such information only to those authorized.
• Conduct daily activities of job responsibilities and projects as assigned.
• Support a safe, clean, and secure working environment by supportingprocedures, rules, and regulations.
• Demonstrated experience in effectively leading quality audits.
• Demonstrated ability to balance multiple high priority responsibilities on-time andeffectively.
• Self-starter with demonstrated organizational, project management, timemanagement, and problem-solving skills.
• Can comfortably and effectively confront difficult situations and issues in a timelyand appropriate manner.
• Strong interpersonal skills - ability to work closely with people at all levels within the STERIS organization and facilitate the implementation of corrective actions;able to work effectively and professionally with external people including suppliers.
• Strong oral and written communication skills.
• Excellent PC skills, including Microsoft Office applications, and the use of AItools.

Additionally, the Lead, Quality and Regulatory Compliance Auditormust have expert working knowledge of the following regulations and standards:

• 21 CFR Part 820 -Quality Management System Regulations (QMSR)
• 21 CFR Part 803 - Medical Device Reporting
• 21 CFR Part 806 - Reports of 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 Application of Risk Management to Medical Devices
• EU Medical Device Directive
• EU Medical Device Regulation

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

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future.

Here is a brief overview of what we offer:

• Market Competitive Pay
• Extensive Paid Time Off and (9) added Holidays
• Excellent Healthcare, Dental and Vision Benefits
• Long/Short Term Disability Coverage
• 401(k) with a company match
• Maternity and Paternity Leave
• Additional add-on benefits/discounts for programs such as Pet Insurance
• Tuition Reimbursement and continued education programs
• Excellent opportunities for advancement in a stable long-term care

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