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Sr Manager Global Quality Systems
Compliance & RegulatoryManufacturing & DistributionColumbus, Ohio, US
Performance Health is seeking a Sr Manager of Global Quality Systems to join our team. This position is responsible for establishing and maintaining Quality System policies and procedures in compliance with applicable global medical device and drug quality regulations across sites. The role is also responsible for monitoring, reporting, and improving execution and compliance of the Quality System across sites.To perform this job successfully, an individual must be able to perform each essential job duties satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.The candidate must live in the eastern or central time zone. Essential Job Duties & ResponsibilitiesLead team in establishing, harmonizing, and maintaining Performance Health’s global Quality System policies and procedures in compliance with ISO 9001, ISO 13485, 21 CFR 201 & 211, 21 CFR 820 and other regulatory/quality standards as applicableEnsure compliant & effective utilization of Performance Health's electronic Quality Management System toolProvide leadership and management of document change control process across sitesEnsure compliant and effective execution of the Quality System globally through use of internal audits, timely regulatory intelligence, and monitoring key quality measures/metricsAs Quality System subject matter expert, interact with and provide process leadership & guidance to global leaders and their teamsAssist the VP of Regulatory Affairs & Quality Assurance and site quality leaders in preparing and conducting periodic corporate level Quality Management Reviews across global sitesAssure Quality Systems processes and execution meet applicable US and international regulatory requirements through establishing and conducting audit plans, and in implementing required corrective actions Provide Quality System subject matter expertise during ISO and FDA site audits/inspections as required to maintain site registrations and certificationsEstablish and maintain supplier Quality agreements, and lead development and execution of supplier Quality audit plansDevelop and deliver Quality System training across sitesPerform data analysis to identify unacceptable trends and risk requiring actionPerforms other duties as assigned Job Qualifications Bachelor’s degree in Engineering, Science or related field10 years of experience working in quality5 years of experience within a medical device regulated industry (e.g. FDA, ISO)5 years management/supervisory experienceDemonstrated understanding of data-driven electronic Quality data analysis tools such as Minitab & Excel pivot tables, and problem solving methodologies such as 6 Sigma, and SPCStrong knowledge and understanding of FDA 21 CFR Part 201, 210, 211, 803, 806, & 820, ISO 14971 and ISO13485 regulatory/quality standardsUnderstanding of UK/European l