Strategically Orchestrated QA Controls: Led the design and implementation of robust Quality Assurance controls via Arena’s eQMS, significantly bolstering our risk management and compliance frameworks. This strategic initiative resulted in substantial enhancements to our tracking capabilities and overall operational efficiency.Streamlined PMA Submissions: Played a pivotal role in refining PMA submission processes, accelerating the achievement by a 25% reduction in time of the critical company milestones.Championed GCP Compliance: Directed stringent GCP compliance during Mock Audits, led quality investigations, and oversaw quality compliance activities across R&D and Commercial Operations. Ensured alignment of Key Performance Indicators with Quality Management Reviews and conducted comprehensive audits of GCP suppliers and service providers, focusing on CAPA adjudications and follow-up.Managed Inspections and Audits: Orchestrated the design and development team’s navigation through Bioresearch Monitoring (BIMO) and Pre-Approval Inspections (PAI), ensuring adherence to regulatory standards. Supervised clinical professionals in implementing corrective actions for clinical documentation systems (CDMS, VEEVA, TMF), GCP Training, and maintained data integrity across internal and external operations.Led Cross-Functional Teams: Developed dynamic progression plans to cross-functional teams of 10-15 associates to balance product development with non-critical tasks, ensuring adherence to PMA submission timelines.Influenced Executive Decisions: Acted as a Regulatory SME, influencing strategic planning for PMA submissions and regulatory approvals within the Executive Leadership Committee.Guided Risk Management Processes: Directed cross-functional teams in Risk Management processes using DFMEA, FMEA, PFMEA and FTA, delivering comprehensive services to customers and patients.

Led Quality Assurance Operations: Directed a team of 15 across five facilities, focusing on Quality Assurance operations and configuration management for Naval contract devices.As the strategic leader of a cross-functional team, I spearheaded a cross-functional team in the transition from our existing system (Agile) to a cost-effective electronic Quality Management System (eQMS) and harmonized QA/RA information systems. This critical initiative was designed to streamline operations, aligning them with both current and future business objectives. The transition also facilitated the development of efficient and effective processes and workflows, enhancing overall operational productivity.Implemented Performance Metrics: Initiated and maintained KPIs, Kaizen, and Gemba practices, leading transformation and sprint activities to enhance operational excellence.Fostered Cross-Functional Collaboration: Partnered with Engineering, Contracts, Legal, PM, Finance, and Operations Leadership to establish best practices and drive continuous improvement.Ensured Regulatory Compliance: Upheld strict compliance with FAR/DFAR, ITAR, and other regulatory and contractual mandates, ensuring meticulous quality standards.Transformed QA Department: Re-engineered the QA team to increase efficiency by 25%, established a QA Supplier Engineering Group, and harmonized cross-functional training, production, design transfer, verification, validation, calibration, and device traceability processes.

Team Leadership and Quality Assurance: Built, mentored, and managed cross-functional teams of 7, focusing on the design, development, engineering, manufacturing, installation, and servicing of Ionizing Radiation Imaging Systems. Regulatory Compliance and Audit Management: Served as an external audit consultant and document review expert for responses to notified bodies. Led Regulatory PMA & 510k submissions, IDE Applications, CE Marking, and directives for MEDDEV guidance. Established, registered, and maintained the Medical Device Reporting system according to 21 CFR Part 803. Strategic QA Controls and QMS Development: Led the design and implementation of robust Quality Assurance controls via Arena’s eQMS, significantly enhancing our risk management and compliance frameworks. This initiative, coupled with the creation and enhancement of a highly successful ISO 9001 & ISO 13485 QMS to ISO 9001:2015 & ISO 13485:2016 standards, resulted in substantial improvements to our tracking capabilities and overall operational efficiency. Additionally, I contributed to software development life cycles and contemporary software quality assurance processes in accordance with IEC 62304.Process Improvement and Risk Management: Organized a root-cause analysis team and developed other problem-solving activities to identify effective corrective actions and process improvements. Utilized ISO 14971:2019 and clinical ISO14155:2020 to assess different risks for design development and business.Product Quality and Compliance: Ensured quality, safety, effectiveness, and compliance of all products designed, manufactured, and/or shipped. Developed quality standards, oversaw the development and execution of software test plans and results analysis. Managed company internal and remote service and repair activities and oversaw the Radiation Control.

Directed a team of 22 professionals in the design, development, contract manufacturing, and distribution of Class II & III Medical Devices. Oversaw all internal audits for ISO certification. Successfully project managed software verification and validation at a major medical company client’s premises. Spearheaded the implementation and maintenance of ISO 13485:2003 and EC Directives. Addressed operational challenges impacting quality, delivery, finances, and work environment, leading to significant improvements. Managed the complaint and vigilance system, reporting quality metrics to senior management for informed decision-making regarding performance reviews and bonus recommendations. Ensured product quality by fulfilling workmanship standards and quality program requirements. Directed and conducted management review meetings and managed TUV, FDA, client, and internal/external audits. Established KPIs and implemented preventive/corrective actions to eliminate root causes of poor quality and delivery. Built and managed vendor relations surrounding QA as part of the selection and performance evaluation team. Developed processes, policies, and procedures for various department areas and trained teams, resulting in the integration of production and QA processes. Led Risk Analysis teams and conducted and orchestrated DFMEAs, FMEAs, and PFMEAs.

(Start-up Venture) As a Quality Assurance Manager, I spearheaded the successful implementation of a comprehensive ISO 9001 & ISO 13485 Quality Management System, optimizing quality across design and change control processes. My role extended to managing Document Control, Quality Control, Shipping, Receiving, and Inventory System departments, supporting Regulatory and Quality Assurance in PMA submissions, IDE Applications, FDA Audits, and internal/external audits. I played a pivotal role in vendor regulation and qualification, employee education on quality impact, and leadership of engineering builds, including clinical builds. My expertise also includes ensuring GCP compliance in clinical trials, managing quality investigations, and overseeing quality compliance activities throughout R&D and Commercial Operations. I conducted Bioresearch Monitoring clinical report audits, ensured Key Performance Indicators supported Quality Management Reviews, and audited GCP suppliers and service providers, implementing comprehensive CAPA assessment and follow-up. Additionally, I was responsible for external QSr and ISO audits, corrective action plans, testing operations, biocompatibility testing, sterilization projects, and medical device packaging management.