• Lead the integration and remediation of Quality System policies and procedures.• Lead the integration budget and Statements of Work (SOWs) for contractors.• Ensure on-time integration as per the defined strategy and related metrics.• Onboard and provide guidance to new workstream team leaders.• Conduct gap assessments and implement necessary process changes with subject matter experts.• Apply expertise to achieve successful audit outcomes and ensure accurate representation of the Quality System during audits.

• Responsible for establishing and maintaining policies and procedures to ensure compliance with local, state and federal environmental regulations and standards• Schedule, coordinate and prepare for Issue Escalation RMB and Quality Review Board Meetings by gathering all required information from all sites/required groups, performing dry runs, managing the process, preparing minutes, following up on action items and maintaining records.• Manage field corrective actions, any associated regulatory actions and follow-ups including support to field action coordinators globally; assist in product problem resolution as part of follow-up from QRB and CAPA.• Track all activities associated with the escalation process to assure compliance with all applicable policies and procedures, including:o Responsible for the coordination of field action activities including preparing documentation for recordable and reportable field actions. o Track customer communications for effectiveness verification.o Complete interim status reports to the FDA at the required intervals. o Prepare or assist leadership with monthly reports. o Lead or participate in process improvement projects.

• Contributes to the development and maintains through continuous improvement the NC/CAPA policies, procedures, tools and guidelines.• Manages the local review board and ensures that NC/CAPAs meet all J&J and external regulatory requirements while ensuring the effectiveness of NC/CAPAs are robustly and effectively managed.• Identify and escalate to management any compliance issues and their potential impact across the franchise so that they can be effectively resolved. • Provide supervision and training, as required for direct reports to manage NCs/CAPAs. Support direct reports in gaining knowledge of all applicable standards, regulations, franchise policies, procedures and work instructions, as per individual development plan.• Conduct project work and team tasks as required to support strategic business objectives.• Contribute to the development of strategic improvements to the NC/CAPA program while assisting staff in ensuring appropriate training and qualifications have been achieved.• Responsible for developing and maintaining through continuous improvement NC/CAPA training content and ensuring training is implemented.• Ensure NC/CAPA program health by providing metrics and reporting to J&J management.• Responsible for generation and publication of compliance data related to NCs/CAPAs.• Interface with all sites and site stakeholders for technical assistance and problem solving in areas of NC/CAPA.• Audits.Serve as a NC/CAPA subject matter expert during audits. Ensure accuracy and completeness of pertinent records and documentation. Responsible for coordination of NC/CAPA data analysis and data review processes for audit readiness.

Working closely with the R&D groups across Acclarent, Advanced Sterilization Products, Biosense Webster, Mentor, Sterilmed, and Cerenovus in driving compliant, effective, and efficient solutions. Specifically, in the areas of New Product Development, Design Control, Design to Value, Project Management, and New Product Development Pipeline Governance.

Working closely with the R&D groups across Acclarent, Advanced Sterilization Products, and Biosense Webster in driving compliant, effective, and efficient solutions. Specifically, in the areas of New Product Development, Design Control, Design to Value, Project Management, and New Product Development Pipeline Governance.

•Perform data and projection analysis on key quality metrics.•Provide backroom external audit support and provide guidance on discussions related to the CAPA process.•Subject Matter Expert and administrator of the electronic database (EtQ) used to store CAPA records.•Evaluate the CAPA Process and relevant metrics to improve communication of the status of the CAPA system to management.

•Lead cross-functional teams to perform in-depth investigations and determine root cause for product issues using root cause methodologies and tools.•Collaborated with cross-functional teams to perform a comprehensive analysis of appropriate corrective and preventive actions.•Applied statistical analysis, tools, and methods to verify effectiveness of changes to address root cause(s).•Oversaw and reviewed 40+ CAPAs to assure appropriate investigation, implementation, and effectiveness monitoring are performed.•Performed data and projection analysis on key quality metrics.•Provided backroom external audit support and provide guidance on discussions related to the CAPA process.•Subject Matter Expert and administrator of the electronic database (EtQ) used to store CAPA records.•Evaluate the CAPA Process and relevant metrics to improve communication of the status of the CAPA system to management.•Developed and introduced the monthly Quality Data Review into the ASP CAPA Process

• Analyze financial and quality data to identify and improve the efficiency and quality of system processes• Develop Excel Visual Basic macros to reduce the amount time and number of resources required to collect and distribute data from various databases• Research current and upcoming regulatory standards to ensure that the quality system in place was meeting regulatory body standards• Develop metrics to review on a weekly, monthly, and quarterly basis for multiple quality system processes to determine if the quality systems are meeting company and regulatory goals• Perform troubleshooting activities for multiple electronic management systems that maintain quality systems• Perform internal audits to review the progression and effectiveness of actions implemented to address CAPA findings. Provide improvement opportunities and recommendations to the CAPA teams• Review and verify that actions implemented for CAPA projects are maintained • Prepare, coordinated, and participate in all internal and external audits including FDA QSIT• Create training materials and conducted training sessions for system, process, and production changes. These changes were presented to different audiences within the organization ranging from operators to directors

• Designed sets of experiments to be used within the R&D department for testing and analyzing electrical properties and output of the electrode array on the Argus II visual prosthetic device• Accelerated the collection of data by automating the testing process and integrating multiple computer programs together into a single process• Examined the effects of using different materials for the experimental design and the variance that the materials can cause on the results• Presented the results of the experiments to quality, R&D, manufacturing, clinical, and regulatory groups to gain input and collaborate for the next steps

• Performed statistical analyses to demonstrate the increased improvements of recovery seen by patients using our experimental therapy compared to conventional physical therapy• Assisted computer engineers in implementing improvements towards creating a more effective database program