OneMain Financial Jobs

Lead, Quality & Regulatory Compliance Auditor Req ID: 52076 Job Category: Regulatory Affairs Location: Mentor, OH, US, 44060 Workplace Type: Hybrid 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. 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 What you'll do as an Lead, Quality & Regulatory Compliance Auditor 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. The Experience, Skills and Abilities Needed 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 saf