Shmulik Guy Email & Phone Number

Caesarea, Israel

Neve Ilan, Jerusalem, Israel

Neve Ilan, Jerusalem, Israel

* Served on the Senior Management team and acted as the Quality Representative within the management structure.* Executed responsibilities as the Site Management Representative, adhering to FDA and ISO requirements and ensured the comprehensive implementation and effectiveness of the Quality System. * Established, implemented, and upheld the necessary processes for the quality system. * Maintained facility compliance with FDA QSRs, ISO 13485, relevant MDD/MDR and Canadian requirements, as well as other applicable International Standards and regulatory mandates.* Provided management with reports on the quality system's performance and any identified areas for enhancement.* Acted as the primary point of contact for external audits and inspections, including those conducted by NB and CE mark regulatory bodies.

Neve Ilan, Jerusalem, Israel

* Implemented policies and procedures that ensured compliance with Quality System Regulations (e.g., FDA Part 820 Quality System Regulation, ISO 13485 Quality Standard) requirements.* Coordinated Management Review and Quality Review sessions in accordance with internal procedures.* Ensured timely identification of CAPA, MRB plans, methodologies for determining Root Causes, on-time completion of actions, and prompt completion of effectiveness actions.* Maintained current knowledge of new laws and regulations, and kept management updated on changes and their operational implications.* Developed and delivered training, interpreted requirements, and provided support to site personnel as needed, contributing to the improvement of their organizational compliance and effectiveness within the quality system.* Qualified suppliers in alignment with company standards and ensured the delivery of quality parts, materials, and services by suppliers.* Formulated and prioritized an auditing schedule to conduct regular audits of designated suppliers, guaranteeing adherence to good manufacturing practices (GMP) and quality standards.* Conducted supplier audits and approved quality agreements. * Oversaw, led, planned, and coordinated audits, offered post-audit support and generated appropriate reports as integral components of the audit program.* Reviewed and authorized validation protocols and reports (Installation Qualification, Operational Qualification, and Performance Qualification - IQ, OQ, and PQ).* Oversaw, monitored, and tracked annual plans for maintenance and calibration activities.* Formulated inspection/testing methods and criteria to evaluate product adherence to specifications.* Provided guidance to engineering/production teams to ensure compliance with procedures, regulations, and standards.

Netanya, Central, Israel

* Ensured Compliance as part of Quality System Management responsibilities and accomplished the following:• Implemented policies and procedures to ensure compliance with Quality System Regulations (FDA Part 820, ISO 13485).• Coordinated Management Review and Quality Review sessions.• Ensured the identification of timely CAPA, MRB plans, Root Cause determination methodologies, on-time completion of actions and timely completion of effectiveness actions.* Managed the facility audits program as Lead Auditor and achieved/delivered the following outcomes:• Led, planned, and coordinated audits and provided follow-up support and report as part of the Compliance Program• Compiled and published a summary report identifying the purpose, scope and assessment results of each audit conducted and coordinated post-assessment meetings with site management to discuss the report, associated risk(s) and any expectations.• Provided guidance to the organization based on external and internal audit results to ensure continuous quality improvement through the facilitation and development of applicable policies, practices and procedures. • Followed-up on internal and external audits/inspection corrective & preventive actions, tracked completions and verified the effectiveness of the actions. * Performed Supplier Quality Management responsibilities as a Supplier Quality Engineer (SQE) and achieved the following:• Received the Star of Excellence Award for reducing product cost. • Qualified suppliers according to company standards and ensured quality delivery of quality parts, materials, and services. • Developed and prioritized an auditing plan.• Ensured accurate and complete preparation of supplier quality engineering documents as required, including process validation plans, incoming inspection planning, and other quality documentation and records.

Or Yehuda, Tel Aviv, Israel

Company's activity - multidisciplinary, develops and manufactures medical device - Optical scanning system creates digital impression with highly accurate virtual 3d impression of patients' crown or bridge area, ensuring an accurate model, which could then be produced by machining machine.