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QUALITY ASSURANCE MANAGEREMAIL AVAILABLE 317-992-8449 LinkedIn Profile Indiana, USA Quality Assurance Manager with over 15 years of diversified experience in leading and enhancing quality practices. Currently spearheading quality initiatives at Hanzo Logistics Inc, ensuring compliance with regulatory standards and ISO requirements. Proficient in conducting internal audits, implementing corrective actions, and maintaining a high standard of performance. Skilled at promoting continuous improvement and achieving excellence in the conveyance of medical devices worldwide. Holds a Master of Public Administration (2023), Master of Business Administration (2018), and a Masters degree in Administration & Management CORE COMPETENCIESWORK EXPERIENCEHanzo Logistics IncQuality Assurance ManagerSep 2023 Current USAResponsibilities and Key Attainments: Spearheaded the collection and analysis of regulatory data, developing comprehensive reports and assessment tools, ensuring compliance verification. Ensure communication of quality metrics, providing management with actionable insights for continuous improvement initiatives. Investigated and resolved product specification issues, contributing to enhanced product quality and adherence to standards. Led and actively participated in internal audits, ensuring rigorous examination of processes to maintain regulatory compliance. Implemented and maintained controls for product safety during warehouse transport, guaranteeing damage prevention and adherence to quality standards. Tracked and trended KPIs and quality metrics, proactively identifying areas for improvement and implementing corrective actions. Established and maintained a high-performance standard in adherence to Quality Management Systems, managing CAPAs and implementing nonconformance programs. Maintained consistency in QA processes, contributing to the overall effectiveness of quality assurance functions. Conducted in-depth inventory research within the Warehouse Management System, ensuring accuracy and efficiency in product tracking and traceability. Development and maintenance of Quality Policy, Quality Objectives, and established corporate Quality Manual. Creation of Corporate level Standard Operating Procedures. Implementation of standardized policy level documentation ensuring multi-site consistency. Obtain and maintain ISO 13485 Certification and FDA QSR Registration. Technical lead on new business pursuits representing Quality System and capabilities. Startup administrator, establishing and managing Quality project timelines. Fedex Supply Chain (Stryker-CDC 2)Quality Assurance SupervisorJuly 2022 Aug 2023 USAResponsibilities and Key Attainments: Expertise in Quality Management Systems (QMS), ensuring adherence to regulatory standards and overseeing Quality Assurance Practices across the facility.Quality Management Systems Regulatory ComplianceData Analysis Electronic Document ManagementISO StandardsSafety Training Operations Excellence Team Supervision Internal AuditsProcess OptimizationContinuous ImprovementCorrective ActionsDocument Change ControlTraining & DevelopmentQuality Driven Management Organizational Communication Critical Thinking Led and Carried out Internal Audits in CDC 1 and CDC 2, resulting in enhanced compliance and streamlined processes. Coordinated Regulatory, LRQA, and ISO Audits, demonstrating a proactive approach to compliance and maintaining industry certifications. Established proficiency in audit execution and collaboration with Quality Management Systems, contributing to the continuous improvement of processes. Implemented effective Compliance and Document Change Control strategies, mitigating risks and ensuring accurate documentation across the organization. Directed the administration of an electronic Document Management System (Intelex), enhancing efficiency in investigation and complaint handling processes. Developed and implemented multiple quality system processes, including feedback programs, contributing to the overall improvement of product quality. Conducted and managed Corrective and Preventive Actions (CAPAs) and nonconformance programs, ensuring swift resolution and continuous improvement. Spearheaded Training and Development initiatives, fostering a culture of quality awareness and skill enhancement within the Quality Assurance team. Authored SOP, Work Instructions, Forms and visual aids. Fedex Supply Chain (Amplify-Lebanon)Operations SupervisorOct 2021 July 2022 USAResponsibilities and Key Attainments: Led daily operational start-up meetings, ensuring adherence to work instructions, daily workflow, and safety protocols, fostering a culture of compliance. Improved training and development programs by facilitating safety trainings and incident reporting, ensuring regulatory compliance with FDA standards. Managed a team of over 35 direct reports, implementing positive coaching and counseling strategies to drive teammate excellence and correct behavioral issues. Developed and maintained a productive work team through cross-training, effective communication, and motivational techniques, achieving prescribed operational objectives. Conducted weekly safety meetings, participated in safety training, JHA reviews, and regular walk-throughs, actively promoting and maintaining a safe working environment. Assessed and enhanced customer service in high-pressure situations, contributing to courteous and respectful interactions with both internal and external customers. Collaborated with the General Manager on special projects, providing valuable assistance and contributing to the successful completion of departmental objectives. Collaborated on the efficient implementation of schedules, ensuring effective job assignments, and minimizing disruptions while meeting customer needs. Actively engaged on the production floor, supervising and leading teammates, demonstrating hands-on leadership to ensure operational success and efficiency. Analyzed and maintained a clean, organized work environment, adhering to corporate 6's standards, fostering a culture of efficiency and quality. Carried out regular assessments of operational processes, identifying areas for improvement and implementing strategic initiatives to enhance overall team performance.Fedex Supply Chain (Stryker CDC 1)Quality Assurance II2019 2021 USAResponsibilities and Key Attainments: Led the implementation of comprehensive quality systems at FedEx Supply Chain, enhancing compliance and document change control, ensuring seamless adherence to industry standards. Developed and executed efficient audit procedures, showcasing expertise in quality systems, and contributing to the enhancement of documentation, quality control, and inspection processes. Administered an advanced Electronic Document Management System, successfully integrating electronic investigation and complaint handling protocols, thereby streamlining and accelerating the resolution of quality issues. Spearheaded the development of multiple quality system processes, notably feedback programs, demonstrating a commitment to continuous improvement and proactive quality assurance practices. Conducted and managed Corrective and Preventive Action (CAPA) initiatives, efficiently implementing nonconformance programs, resulting in a significant reduction in quality-related issues and improved operational efficiency. Showcased Subject Matter Expertise (SME) in Holds & Releases, contributing to the proficiency of the Quality Event Notification(QEN) and Non-Conformance Report (NCR) training and development, fostering a culture of quality excellence. BellTech Logix ( a subsidiary of EPSON America Inc ) Quality Systems Specialist/Team Lead2017 2019 USAResponsibilities and Key Attainments: Led daily operations optimization by directing staff based on business needs, enhancing efficiency in Depot receiving activities through the creation of MS Access applications for comprehensive analysis. Managed and executed audits, FPA, OBA, and general inspections of EPSON products, ensuring compliance with quality standards, utilizing SAP software for data capture to generate insightful executive reports. Developed and implemented Work Instructions, SOPs, and Controlled Logs, fostering a standardized approach to processes, enhancing organizational efficiency and adherence to quality protocols. Collaborated on the utilization of Warehouse Management Systems, contributing to the streamlined analysis of receiving activities, and conducted thorough investigations to identify and address potential quality issues. Assessed and improved the overall quality system by actively participating in core audits, employing SAP for data capture, and contributing to the continuous enhancement of quality processes for sustained organizational excellence. Royal United Nig LtdHuman Resource Business Partner2012 2016 NigeriaResponsibilities and Key Attainments: Spearheaded comprehensive Talent Acquisition strategies, successfully recruiting and onboarding top-tier talent Established proficiency in Training initiatives, conducting impactful programs that resulted in a skilled and motivated workforce. Demonstrated expertise as an Employee Benefit specialist, implementing benefit programs that enhanced employee satisfaction and retention. Pioneered the transition to E-documentation & Filing systems, ensuring a seamless and paperless workflow. Support Warehouse Management to ensure Quality Control of electrical devices is strictly adhered to. Resource Intermediaries LimitedHR/Admin Generalist2010 2012 NigeriaResponsibilities and Key Attainments: Orchestrated seamless admin management, overseeing the development and proficient management of desktop applications on Windows operating systems Implemented robust internal control measures, ensuring strict adherence to regulations and fostering a compliant work environment for sustained operational integrity. Spearheaded comprehensive general administration initiatives, optimizing resource allocation and streamlining processes for heightened productivity and cost-effectiveness.Softskills Management ConsultantsHR Consultant Trainee2006 2008 (Part Time) NigeriaResponsibilities and Key Attainments: Participated in project management initiatives, data collection and analysis through advanced applications such as MS Access. Streamlined staff analyses processes, enhancing efficiency and accuracy in decision-making for human resource operations. Active member of team to oversaw end-to-end project lifecycle, showcasing strong organizational and time-management skills Enhanced team productivity by implementing data-driven strategies, contributing to the success of projects Halliburton Energy ServicesAdmin/HR Associate2003 2006 (Part Time) NigeriaResponsibilities and Key Attainments: Optimization of HRD systems, PPROL and ILEARN, resulting in a notable increase in overall utilization and efficiency. Implemented strategic enhancements to streamline processes within PPROL and ILEARN, fostering a more user-friendly and accessible experience for all stakeholders. Issuing new employees with enrollment documents Responding to HR-related queries within the company. EDUCATIONDoctor of Business AdministrationIndiana Wesleyan University, IN-USA In ViewMaster of Public Administration 2023Indiana State University, IN-USAMaster of Business Administration 2018Ladoke Akintola University of Technology, NigeriaBachelors in Accounting & Finance 2007Olabisi Onabanjo University, NigeriaMaster in Administration & Management 2018University Of Lagos, NigeriaACHIEMEMENTSCertifications:Internal Auditor Certification ISO 13485:2016 and ISO 9001:2015, LEAN Six Sigma- White Belt CertificationAwards:Ken-Tye Plus Leadership Awards, Legacy Awards of Excellence, Three-time Bravo Zulu Awardee, One- time Purple Promise AwardeeStart-up andImplementation:Established Quality, Inbound, and Outbound Departments, Launched Quality Assurance Department in two different FedEx PlantsQuality Assurance: Set up Outbound Quality Audit system to prevent errors in medical device shipment QMS Establishment:Established QMS System for HANZO Logistics Inc and authored SOP, Work Instructions, Forms. PUBLICATIONS1.Quality Assurance in Medical Device Supply Chain (Under consideration for publication with ASQ) Optimized QA in medical device supply chain for defibrillators and Heart Sine Implemented streamlined logistics and QC processes. Enhanced timely delivery, improving patient care and healthcare resilience 2. Quality Management System in Healthcare (Under consideration for publication with ASQ) Explored QMS as a tool for enhancing healthcare effectiveness in America. MEMBERSHIPSAmerica Society for Quality Indiana Association of HealthCare Quality Society for Human Resource Management Chartered Institute of Personnel Management LANGUAGESEnglish - Official Igala - Native Yoruba-Native Hausa - Native |