Direct, manage and provide oversight for all activities related to the Quality Management Systems, Operations and Performance Improvement for Start Up Medical Device/Combo Products. Lead the Quality/Regulatory department, with the leader and coaching approach to 1 QA/RA Manger and 10 QA/RA Engineers. Lead diverse remediation projects and stakeholders across the organizations. Develop and maintain the quality plan to ensure industry best practices, oversees the implementation of the organization

Lead the overall QMS Process Improvement due to 483s remediation projects. Serve as the QMS SME, leading Stakeholders on the development of robust and compliant QMS processes. Serve as SME on QMS Kaizen events, provide expertise on industry best practices and guidance on future process maps for different workstreams. Lead different Kaizen projects workstreams on successful completion on action items and tasks assigned. Served as the regulatory requirements expert, to drive QMS processes.

Divisional leader for the QMS and CAPA Program. Responsible for diverse sites within the organization, leading and supporting project needs, resources allocation, tasks assignments and tracking on-time completion. Leverage the CAPA process to integrate into the CSS/Ethicon Franchise CAPA Process. Manage the CAPA remediation activities, leading the activities to completion from the different workstreams. Manage and conduct weekly CRB meetings. Assess legacy/aged CAPAs and prioritize all open CAPA

Execute project planning, strategy and management of the QMS software deployment and implementation for multiple major medical device and Pharma organizations within the regulated industry. Provide consultancy and expertise on the QMS regulation elements requirements and potential improvement to the current QMS processes to align with the OOB workflow and configuration needs. Lead the client on their requirements gathering and lead the software technical team on the design of the QMS processes.

Execute Planning, implementation and deliverables tracking for the organization’ s new Global QMS. Manage and track project deliverables with the different workstreams and stakeholders to ensure on time completion. Define the scope of the project in collaboration with client senior management. Create a detailed work plan which identifies and sequences the activities needed to successfully complete the project. Developed Communication Plan between the IT Business Partner, QMS Corporate and all 4.

Implementation and Management of QMS for diverse customers. Helping customers with the implementation, remediation and harmonization/integration of QMS. Resources management, project and structure planning, business strategies. Driving implementation of QMS Processes from scratch.