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.

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.

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.
• 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.

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.