• Led the cross-functional Team of Consultants in 16 different workstreams for a complete QMS Gap Assessment and Remediation project.
• Edit, released, and implemented the Overall QMS Quality Plan for Mölndal site, plus 16 child Quality Plans for all the workstreams under the remediation effort.
• Provided a detailed Gap Assessment to the Production & Process Control Workstream.
• Mölndal Site Process Validation Lead.
• Managed the Internal Audit Workstream
• Managed the Management Control Workstream
• Managed the Manufacturing Software Workstream
• Managed the Facility Control Workstream.
• Provided Test Method Validation Training to the R&D organization.

Equipment & Facility Maintenance & Calibration Lead. Abbot Libre 2 & 3 Glucose Meter Equipment Maintenance & Calibration Remediation. Edit and release the Equipment Maintenance and Calibration Program for the Buffalo Grove, IL, and the Austin, TX Flex facilities.

• EU MDR Assessment & Remediation for Israeli Acquisition of Lumenis Medical Lasers & Optical Fibers.
• Assessment of the Software Package Mose 2.0 for the Holmium Medical Laser System, and the system interfaces.

Design transfer and change control assessment for EU MDR NB Certification.
• FemoSeal Vascular Closure Device - EU MDR Assessment
• Angio Seal VIP Vascular Closure Device - EU MDR Assessment

Design Control EU MDR ASSESSMENTS (100% Remote Support Project)
• HPS Laser System & Laser Fibers EU MDR Assessment
• New Generation UroMax Balloon Catheter
• XPS Laser System and Laser Fibers

Design Control EU MDR Assessment (100% Remote Support Project)
• ISO 13845 & EU MDR Design Control DHF Gap Assessment including: design input, design output, design verification, design validation, design review and design transfer phases documentation review for 1- Endometrial ablation (Intrauterine Tissue Removal) DHF Regulatory Assessment for NovaSure Advanced Ablation Device and NovaSure Controller Unit. 2- MyoSure Hysteroscopic Tissue Removal Devices (LITE, REACH, FLUENT and New Generation XL Devices), MyoSure Controller 10-550, and Fluid Management System Controller.
• EU MDR Gap Assessment Report and Remediation Project for NovaSure and MyoSure Products. Test Method Validation Gap Assessment for the Design Control Review in both Medical Devices.

• Schaumburg, IL. Managed Software Master Validation Plan and lead the Hearing Products Software Validation project. Validation of SoundCheck 16 Software for R&D lab use. Lead the Test Method Validation Validations for Echo-Screen III, ALGO 3i, and ALGO 5 infants hearing screening devices. Managed the creation and release of protocols, their execution, and reports.
• Seattle, WA. Lead and Performed Test Method Validation Gap Assessments Project for the neoBLUE Blanket (Neonatal products) as part of the 483 Warning Letter CAPA Project. CAD Test Fixture design, and Fixture IQ validation. Drafting and planning the TMV remediation activities. Labeling support to the Global Natus Labeling Project.

• Validation of the UDI Laser Marking Equipment for Orthopedic Implants.
• Engineering Study Protocol (Robust DOE) for Laser Marking of Titanium, SS, and Peek.
• Software Validation for FOBA Laser Marking Software – MarkUS 2.11
• IQ, OQ and PQ Validation of the FOBA Laser System M3000P
• Master Validation Plan Report Update.

Hungary Sárvár's Flex facility.
• Support the Company in multiple engineering roles as:
• Production PLC code review, correction, and validation project.
• Laser Safety Assessment for Contract Manufacturer (FLEX) Factories in Suzhou China and Buffalo Groove, IL.
• Support the automation engineering team in San Francisco, CA for new production equipment User Specification Review for the 100% Automation operation in Sárvár, Hungary.
• Support the Laser Marking Equipment design team, to provide highest manufacturability grade in Netherland, at the system integrator site.
• Support the Quality System Team by Developing Validation Protocols (IQ-OQ, PQ), execution and review/disposition the corresponding Validation Reports.
• Support e-Liquid CAPA Project.
• Support the Quality System Team Improve the Statistical Analysis SOP, by reviewing and upgrading the Company Statistical Method SOP, and Sampling Plan SOP.
• Support the Review of the Process Validation SOP and the IQ, OQ, and P

• Provide Training to Junior engineers and improve the Incoming Inspection Measurement Systems. Develop TMV Protocols, release and approve Validation Reports.