Dani Bar-Lev Email & Phone Number

Israel

Acting as a Senior Management Representative for Quality Assurance at the company.Directing the Site Quality Management System activities, processes, strategies, infrastructure, regulatory strategies and submissions, Clinical processes.Establishment and Implementation of QMS programs on site, set the overall company road map and strategy for global regulations requirements within the organization, including cross-functional and site-specific processes. The role is responsible for company compliance covering voluntary, regulatory and company quality requirements and will champion quality Initiatives at all levels of the organization.Overseeing all QMS related communications and training requirements for all employees.Establishing positive relationships with outside regulatory agencies.Ensuring site audit readiness and hosting Quality System audits and regulatory body inspections.Overseeing the Corrective Action / Preventive Action activities, Complaint Handling Programs, Manufacturing, Supplier assessments, qualification, evaluation and control, Risk management, and site design controls programs (NPI's).Report on Quality System effectiveness and requirements to top management team, preparing and executing facility Quality Management Reviews.Driving the definition of site quality objectives, metrics, reporting and operating mechanisms.Implement global QMS and regulatory changes on site.Mentoring on best practices in QARA industry, driving changes in site behavior culture to implement strong foundations as a medical device company.Define and establish GMP regulations in production. Control and evaluate clinical trials processes according to ISO14155Work closely with External laboratories/suppliers and worldwide certification centers to meet different safety and efficiency regulations.

Israel

Acting as a Management Representative for Quality Assurance & Regulatory Affairs at the company.Directing the Site Quality Management System activities, processes, strategies, infrastructure, regulatory strategies and submissions, Clinical processes.Establishment and Implementation of QMS programs on site, set the overall company road map and strategy for global regulations requirements within the organization, including cross-functional and site-specific processes. The role is responsible for company compliance covering voluntary, regulatory and company quality requirements and will champion quality Initiatives at all levels of the organization.Overseeing all QARA related communications and training requirements for all employees.Establishing positive relationships with outside regulatory agencies.Ensuring site audit readiness and hosting Quality System audits and regulatory body inspections.Overseeing the Corrective Action / Preventive Action activities, Complaint Handling Programs, Manufacturing, Supplier assessments, qualification, evaluation and control, Risk management, and site design controls programs (NPI's).Report on Quality System effectiveness and requirements to Senior management team, preparing and executing facility Quality Management Reviews.Driving the definition of site quality objectives, metrics, reporting and operating mechanisms.Implement global QMS and regulatory changes on site.Mentoring on best practices in QARA industry, driving changes in site behavior culture to implement strong foundations as a medical device company.Responsible on CE and FDA approach strategies and submissions for company products.Define and establish GMP regulations in production. Control and evaluate clinical trials processes according to ISO14155Work closely with External laboratories/suppliers and worldwide certification centers to meet different safety and efficiency regulations.

Israel

A senior management member of the Respiratory and Anesthesia business @ GEHC Israel.Acting as Management Representative for Quality at the Site.Directing the Site Quality Management System, fully integrated into the GE Global Quality Management System, including cross-functional and site-specific processes. The role is responsible for facility compliance covering voluntary, regulatory and company quality requirements and will champion quality Initiatives at all levels of the organization.Overseeing all Quality-related communications and training requirements for all site employees.Establishing positive relationships with outside regulatory agencies.Ensuring site audit readiness and hosting Quality System audits and inspections.Overseeing the Corrective Action / Preventive Action activities and Complaint Handling Programs, and in some cases, Quality Engineering.Report on Quality System effectiveness and requirements to management team, preparing and executing facility Quality Management Reviews.Driving the definition of site quality objectives, metrics, reporting and operating mechanisms.Participating in selected global initiatives to share best practices and leverage quality synergies.Implement global QMS and regulatory changes on site.

Israel

Lead plant-wide effort to reduce scrap and rework costs, identify root causes and solutions for quality defects and production holds.Provide leadership and coaching for site calibration and receiving inspection teams.Work seamlessly with QA/RA teams to ensure optimal performance of the site in meeting customer, business and regulatory commitments.Ensure meaningful and timely resolution of CAPA’s, NC's and supply chain/operations investigations.Coach process engineering team on tools and practices required to drive day-to-day improvements in the quality of processes.Work with design, manufacturing, and NPI teams to drive changes that will reduce quality issues and result in higher long-term reliability.Leverage supplier quality and material resources to make real improvements in the quality of supplied materials.Protect the integrity, effectiveness and timeliness of change validation process.Complete all planned Quality & Compliance trainings within defined deadlinesIdentify and report any quality or compliance concerns and take immediate corrective action as requiredEnsures the creation of accurate, complete and timely records and medical device DHRs.

Israel

Managing & leading 25 engineer’s as a direct manager, recruit new employees and sustain current with career development, mentoring in a performance based environment. Establishing positive and productive relationships with site internal customers (Eng., R&D, Purchasing, QARA, Sourcing, Sales and Service teams).Implementing global best known practices at production line & infrastructure (NFF, MRB, MTBF, DPPM, FIFO, LIFO, LEAN)Responsible on NPI product transfer to production and design improvements from productivity and serviceability stand.Clean room work environment (Class 1-1000), control and monitor safety requirement (PPE) for all employees.Define and set production KPI’s, meet operational business goals and targets.Work alongside with global Service teams to deliver world class reliability and serviceability products.Meet quarterly business and operational Performance objectives.Deliver Operations projects on-time, in-budget and to-specification.Create & deliver Manufacturing build plan to business sales demands.Support maintenance & development of ISO9001:2008 Quality Management System requirements.Responsible on all MRB inventory, costs reduction, rework and repair activities.

Israel

Responsible on 45 strategic suppliers, managing ~$120M purchasing orders per year, setting supplier expectations and working methods.Identify, develop, and manage effective relationship with existing and potential new suppliers of goods and services to meet the established cost, quality and delivery targets. Monitor and report supplier scorecard performance on monthly basis.Establishes and manages production scheduling activities by monitoring material inventories, tracking progress of production and reviewing factors that affect schedules. Responsible for accuracy of inventory counts by implementing and managing, in conjunction with Finance, and inventory control systems.Reporting to Senior Supply chain manager

Israel

Responsible on production line products as a technical expert, repair, rework and release activities. Support global product upgrades implementation activities at customers' sites (Fabs).Defines customer upgrades/rework scope, content, delivery & execution to gain high customer satisfaction.Lead manufacturing of Critical dimension devices per customer sales orders, different configurations, set ups and requirements.

Israel

Responsible on inventory planning, schedules and delivery to logistic centersResponsible for overall purchase orders generation, fulfillment and signoff.Managing inventory control and counting per quarter.Managing overall distribution channels from main logistic center and resources.

Bachelor'S Degree, Business Management & Economics

Specialization in Marketing

Engineer'S Degree, Industrial Engineering

Specialization in Manufacturing

Diploma Of Education, Mechanics - Aviation

Specialization in Aircraft mechanics and systems.