Directed Quality teams at California and South Carolina locations, oversaw product manufacture and distribution quality. Led teams in providing Management Controls, Quality Engineering, Quality Systems, Document Control, GMP Training, and Internal/External Audits.•Rebuilt the site Quality Team, including new hires for Senior Quality Assurance Manager, Quality Engineers (2), QC Supervisor, Quality Associates (2), and a Document Management Associate. •Team implemented process controls and improvements to product quality, new product introduction, document control and training, quality control inspection, and quality system elements which met and exceeded established site objectives.•As the Quality Management Representative, guided the audit teams through successful ISO 13485-2016 MDD/MDSAP Quality System audits at both sites. Corrective actions for findings (2 total) and observations were completed on time and accepted by the notified bodies during subsequent audits.

Accountable for compliance of Quality Systems by leading activities specifically tied to Management Controls, Management Review, and Quality Metrics. Identified and addressed potential and existing quality and regulatory issues and streamlined quality system procedures to ensure an effective quality management system.•Established a comprehensive management review meeting program for local and international sites, effectively documenting quality objectives and metrics reporting. This program emphasized adherence to objectives and accuracy in reporting as directed by senior leadership.•Instituted a stringent tracking system for all assigned action items, ensuring they were diligently tracked to closure and reported to senior leadership, enhancing accountability and follow-through.•Pioneered implementing a unified SharePoint-based system, accessible to domestic and international sites and departments, to consistently record monthly metric data.•Utilized Power BI to develop a dynamic dashboard that aggregated and displayed metrics controlled by the respective responsible departments and sites. This dashboard served as a pivotal tool for the visualization and analysis of data during quarterly management review meeting presentations.

Led international team of 10+ analysts performing complaint and field service investigations and timely submissions to applicable regulatory bodies, including role as the corporate CAPA coordinator, provided expertise, guidance, risk assessment, and oversight to CAPA owners.•Managed international complaint handling and reporting team, investigating 35,000 customer complaints annually. Initiated automated data collection for trending reports and performance scorecards to Executive Leadership, 3rd party vendors, R&D, and post-market surveillance teams.•Drove standardization of global QMS processes across 12 sites (US and OUS) by implementing the Agile electronic Quality Management System (eQMS). Business administrator activities included system modifications, risk management review, procedure maintenance, and employee training.•Developed interactive dashboards for global QMS metrics and trending that were approved for utilization for product quality teams, new product development, and corporate management review meetings.•Co-lead company’s initial on-site Stage II MDSAP (ISO 13485-2016) assessment audit resulting in only two minor (Category 3) findings.•Implemented and administered compliance wire electronic Learning Management System (LMS) to 8,600 global end users, automating employee GMP procedure training notification and completion tracking.

Ensured compliance with national and international standards and regulations for complaint handling and reporting, product returns, and submissions to regulatory agencies. Generated implantable device complaint data for submissions sent to the FDA.•Managed 12 technicians investigating 18,000 international complaints annually; reported complaint data to the FDA quarterly; processed $3.25 million in product returns. Provided trend data for post-market surveillance, R&D investigations, CAPA analysis, and presentations for management review meetings.•Transitioned the complaints management process to a new eQMS (Agile PLM) to prevent possible data loss on schedule. Project scope included validation, procedure rewrites, and team training.•Managed quality assurance/quality engineering, calibration, and in-process/final inspection with staff of 45+ direct employees. Provided strategic direction for the department by supporting new product introduction and sustaining current products and processes.•Directed the Quality Engineering (New product development, Supplier Quality, process improvement), Calibration, Quality Assurance (In-process/final inspections) and Quality Control Inspection departments.•Implemented QMS processes and policies; managed the Quality Engineering, Calibration, Document Control, and Training departments. Projects included developing a division-wide training program and implementing Quality Systems Metrics (complaints, CAPA, validation, and document control).•Represented Quality Assurance during transfer of manufacturing operations. Hired and on-boarded staff, defined department responsibilities, updated procedures, and validated integration of processes.