David Dejeu, Cqe Email and Phone Number

• Led Supplier Quality Engineering group and managed medical device and drug combination product suppliers across business unit.• Restructured Supplier Quality team to significantly improve internal group and cross-functional communication.• Supported OEM sales team for external business customers by defining company commitments, assessing internal capabilities, evaluating product lineup, and ability to meet customer needs.• Reviewed and negotiated Sales and Quality Agreements for external customers with OEM Sales team.• Led strategic projects to drive business value, process optimization, and regulatory compliance. • Managed projects including creation and implementation of Production Part Approval Process (PPAP) and Supplier Change Request Portal, resulting in optimized supplier communication, streamlined business processes, improved part quality, and reduction in overall total cost of quality.• Facilitated meetings and influenced direction of corporate initiatives. Led onsite trainings globally to ensure implementation and adoption across international sites.• Performed quality system and technical audits at vendor locations, including clinical trial suppliers, contract manufacturers, and critical suppliers.• Collaborated with cross-functional teams to support new product development (NPD) and drive continuous improvement at existing suppliers.• Proposed and developed software solutions including Supplier Scorecard Tool using Visual Basic following SDLC from planning through deployment/release.

•Oversaw Quality Control Lab, Calibration/Metrology, Incoming Inspection, & Microbiology at a medical device manufacturing site producing PMA/Class III devices in a Class 7 cleanroom.•Responsible as Site Quality Head and hosted regulatory body, supplier, and internal audits of manufacturing site to demonstrate regulatory compliance of the quality management system.•Worked with OEM Sales team to support external customers evaluating manufacturing site capabilities. •Collaborated with customers on engineering feasibility of desired products, design and manufacturing recommendations, as well as potential risks and solutions related to their project.•Acted as a liaison between customers and internal product management and engineering teams to address customer needs and drive product improvements.•Provided post-sales support, including resolving technical issues and investigating product complaints.•Served as project manager for implementation of Statistical Process Control (SPC) software to improve manufacturing data performance monitoring. Provided real-time insight into quality issues and established a baseline for future performance optimization and cost reduction projects.•Promoted Lean Manufacturing initiatives. Engaged in Kaizen Events to eliminate waste, reducing process cycle time and improving process yield while maintaining quality.•Used Six Sigma methodology to optimize manufacturing processes and drive operational excellence.•Participated in Design Reviews of products prior to design transfer and product commercialization.•Developed manufacturing inspection software solution using Visual Basic and SQL to eliminate manual data collection errors and specification comparison errors, while reducing inspection time by over 50%.•Performed Computer System Validation (CSV) for off-the-shelf and custom software & manufacturing and test equipment as part of the software development lifecycle.•Managed black box and white box software testing.

• Responsible for quality control and compliance of manufacturing site producing Class III implantable medical devices.• Supported OEM Sales team by presenting manufacturing site capabilities and addressing customer requirements.• Collaborated with customers to develop new product manufacturing processes and design solutions.• Managed Material Review Board (MRB) to address handling of non-conforming product.• Led Validation Review Board (VRB) to assess validation requirements using risk-based approach.• Developed test methods and conducted test method validations for manufacturing process inspections.• Conducted investigations into pyrogen failures and implemented system controls to prevent recurrence.• Reviewed and updated Design and Process FMEA risk management documentation.• Developed and executed Design of Experiments (DOEs) to perform root cause investigation within complex manufacturing processes.

• Supported Biopsy and Angioplasty device franchises throughout product lifecycle, including new product development, manufacturing, and post-market lifecycle support.• Managed Corrective and Preventive Actions (CAPAs) triggered by product complaints.• Planned and executed process validation protocols and reports (IQ, OQ, PQ).• Performed verification and validation of product design changes for existing products. • Managed projects to establish new specifications for legacy products based on gap assessment and user needs analysis.• Retrospectively evaluated reliability of reusable equipment through statistical analysis of complaint data. • Led investigations into bioburden and endotoxin excursions at international manufacturing facilities.• Supported sterilization dose audits and dose augmentation studies to ensure continued sterility of product without impact to shelf life or product performance.• Attended clinical cases to conduct field research for future product improvements.

• Provided data analysis and presented solutions to remediate complaint records and comply with newly introduced regulatory requirements• Developed and implemented procedures and work instructions• Reviewed engineering drawings, specifications, and bill of materials for accuracy

• Analyzed clinically recognized cerebral aneurysm geometries and hemodynamic responses using computational fluid dynamics to determine efficacy of simulated treatment scenarios in CAD models.o Work supported development of SurgicalPreview® software currently marketed by RapidAI.• Performed quantitative analysis using Abaqus Finite Element Analysis, ANSYS Fluent, and TecPlot.

• Translated market research observations into unmet customer needs and worked with engineering team to develop strategic solutions for containerized mobile medical clinic in underserved rural areas

• Repaired and tested donated medical devices and equipment to ensure functionality• Led volunteer groups and trained new interns to ensure quality requirements were met

• Responsible for all aspects of order management, including prioritizing duties, fulfilling online orders, packing and shipping merchandise, training new associates, high volume cash register operations (up to $1000), customer service, and assisting in other areas as needed.• Surpassed goal for online order processing, completing up to 700 orders per day

• Managed branch of house painting business including finances, employees, & customer satisfaction• Marketed & advertised services resulting in $40,000 revenue from 11 booked jobs• Managed schedules of up to 7 employees at a time, coordinated material purchase, executed payroll• Interviewed, hired, & managed all aspects of employee performance, including termination.