- Ensure Compliance of the Global Quality Management System (QMS) to the most current version of applicable International Medical Product (Device, Rx, OTC, Biologic) Regulations and Standards through effective implementation, training, and monitoring- Establish and manage Global Internal and External Audit Programs including Interface with external agencies as required including the FDA and the Notified Body - Partner with Global Regulatory Affairs to assure integration of Regulatory Intelligence activities and changing expectations into the QMS- Develop company-wide Quality compliance roadmap and define priorities in line with global requirements and existing compliance gaps including the development, installation and monitoring of Global Quality Policies and Procedures- Define global processes & collaborate with the site Quality Heads to ensure execution on site level, supporting the site leaders as needed - Harmonize the quality compliance standards and ensure they are aligned across functions- Collaborate with Global Site Quality Leaders to establish and execute digital strategies for Global Quality and Compliance Data - Facilitate Global Quality Management Review for the Global Leadership Team - Establish a global system for routine review of quality system data, including internal/external audit results to determine compliance gaps and associated mitigation plans on a global level- Define, implement, and improve tracking mechanism for compliance progress - Allocates human resources and selects, acquires, and deploys appropriate methodologies to fulfill near term goals and commitments while ensuring sustainable quality performance- Motivates and leads their organization to achieve business objectives

- Oversee the Quality Management System and ensure compliance to FDA cGMP (QSR), ISO 13485, MDSAP and CE-MDD/MDR requirements- Assist management in company strategy, goals, action items, and metrics - Participate in management reviews and company/project steering committees- Represent the company in IEC Technical Committee SC 62C, Equipment for radiotherapy, nuclear medicine and radiation dosimetry- Manage the internal audit and external inspection programs, including FDA inspection, supplier and notified body audits - Coordinate and implement integration planning and due diligence activities for acquisitions - Oversee all domestic and international product approvals, clearances, and registrations; Official Correspondent to the FDA - Direct the implementation of new medical device regulatory requirements including product standards compliance and testing- Oversee all product risk assessments and the General Safety and Performance Requirements- Manage the Corrective & Preventive Action program for the facility - Maintain Post-Market Surveillance/ Periodic Safety User/ Clinical Evaluation report activities- Provide regulatory related customer support of service, complaints, and field action- Support Agile software development and engineering testing processes, and manage the Design History File/Technical Files of over 50 product lines- Oversee all Quality related training for the facility

Oversee Quality Assurance and Regulatory Affairs at Standard Imaging- Participate on the Management Team and the Project Steering Committee- Assist Management Team regarding company strategy, goals, action items and metrics- Manage the quality management system (QMS) and ensure compliance to FDA cGMP, ISO 13485, and MDR requirements- Manage domestic and international product approvals, clearances and registrations- Represent the company on applicable committees, SC TAG 62C- Provide guidance on project and product management- Support product standards compliance efforts and testing- Support the product design teams and participate in design reviews- Support process and product validations- Support Post Market Surveillance/ Periodic Safety User Report activities

Research Park Sr. Site Quality Assurance Leader- Maintain the quality assurance of three different modalities, focusing on numerous program launches and production activities, while supporting design activities for over 25 product lines- Manage a team of nine direct reports, executing to defined plans to ensure proper implementation of multiple programs of the quality system; mentor and coach various cross-functional individuals- Engage with business leaders to ensure the compliance of government regulations and strategize to meet business objectives - Drive the evolution of the quality culture for all levels of the organization with defined goals and metrics- Champion global initiatives to share best practices and leverage quality synergies - Support audits in China, Japan, Korea, and US

Site Quality Leader in Seoul, Korea- Developed the quality and regulatory systems by ensuring that the procedures and processes are in compliance with all required standard and regulations- Managed a team of five direct reports, allocating the right resources for Quality System implementation- Analyzed, evaluated, and presented information concerning quality trends to senior management team through weekly Quality reviews, monthly complaint reviews, and Quality Management reviews- Participated in program launches as a reviewer and approver for project milestones and design reviews- Provided leadership and training on the Quality Management System for all employees - Engaged in continuous improvement projects with global teams, as a change agent, to simplify quality processes and procedures, while communicating with the local team on global initiatives

Quality Engineer for X-ray- Generated detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, design outputs, validation activities and program risks- Supported continuous product and process improvement through detailed failure analysis - Participated within a cross-functional team for product development, design change control process, and production process control

Quality Assurance Engineer- Facilitated as a cross functional team leader/change agent for various continuous improvement projects- Completed several projects and Kaizen events resulting in over $500,000 of base-cost savings - Calculated defects per million and complaints per million for each product manufactured- Reviewed procedures and submitted Engineering Orders for procedure updates- Instructed as the internal process trainer for both Quality and ManufacturingLean Six Sigma- Utilized matrix management through Lean Manufacturing and Six Sigma ideologies of DMAIC and 5S- Conducted and analyzed Measurement System Analysis, Gage R&R, and Process Control Charts - Gathered and extrapolated data for upper management using statistical analysis through Minitab - Implemented inspection sampling plans and conducted risk analysis using Process/Design FMEA Laboratory Technician- Collected chemical samples and completed analysis for filtration and titration methods- Monitored environmental suites of ISO class 5 using particulate counters and microbial air tester - Evaluated ISO class 7 and 8 Clean-room surface and particulate sampling