פרופיל תעסוקתי:

eucation:
2025- ISO 14971:2019 Risk Management for Medical Devices, BSI
2024- V&V Seminar, Gstudy
2023- Internal auditor ISO 13485-2016, BSI
2019-2020- CQE , MASAD college
2017- Quality Assurance and internal audits, Nazareth Illit college
2009-2013- B.A Social Sciences - Business Administration specialization, Emek Israel college
2000-2006- High school full matriculation “ORT Sharet” School.

work Experience
2019- present- VIORA LTD- Golbal Quality assurance Senior Manager
• Global QMS Management: Overseeing and maintaining the Quality Management System (QMS) for
multiple corporate entities, ensuring full alignment with MDD, MDR, ISO 13485:2016 and MDSAP
requirements.
• Regulatory Audit Leadership: Serving as the official Management Representative during Notified Body
audits; successfully maintaining CE and MDSAP certifications through rigorous compliance oversight.
• Vigilance & Complaint Management: Leading the end-to-end investigation process for customer and
supplier complaints. Implementing structured root cause analysis (RCA) and ensuring timely regulatory
reporting in accordance with global vigilance timelines.
• Budgetary Oversight: Responsible for the Quality Assurance department's annual budget, including
resource allocation, cost-effective management of external lab services, and justifying investments in
quality tools and infrastructure.
• Process Improvement & Lean QA: Driving continuous improvement initiatives across production lines to
optimize efficiency while maintaining strict quality standards.
• CAPA & Effectiveness Monitoring: Managing the Corrective and Preventive Action (CAPA) system,
including the design and execution of Verification of Effectiveness (VoE) plans to ensure long-term
resolution of non-conformities.
• Subcontractor & Supplier Oversight: Performing monthly quality performance measurements for
subcontractors and managing supplier quality through audits and follow-ups
Team Leadership: Managing and mentoring the Quality Control (QC) team, fostering a culture of
excellence and high regulatory awareness.
• Configuration & Change Control: Directing the configuration management system and overseeing all
Engineering Change Orders (ECO) to ensure technical document integrity.
• Training & Certification: Managing the training matrix and certification programs for production
employees to ensure 100% compliance with work instructions.
Core Competencies & Skills
• Vigilance & Regulatory Reporting: Expert in global medical device reporting (MDR MDSAP),
including managing strict 2-day/10-day reporting timelines and implementing advanced Vigilance
Decision Trees.
• Root Cause Analysis (RCA): Highly proficient in systematic investigation methodologies, including
-
Whys, Fishbone (Ishikawa), and technical/clinical impact assessments.
• Audit Readiness : Proven track record in leading Notified Body audits (DEKRA, BSI etc.) and
successfully resolving Major Non-Conformities (NCRs) through robust CAPA planning.
• Risk Management: Deep understanding of ISO 14971, including the integration of complaint data
into Risk Management Files (FMEA) and benefit-risk profile evaluations.
• Documentation Excellence: Expertise in drafting technical justifications and rationales that
withstand rigorous regulatory scrutiny, specifically for non-reportable events and CAPA
determinations.
• Quality Leadership: Experienced Management Representative with a focus on lean QMS structures
and cross-departmental compliance integration.
2016-2019- R.H. Electronics, Quality Leader -production for electronic production assemblies and systems
to global customers in a diverse range of industries.
• Managing a team of quality Control
• Quality management in medical devices manufacturing projects
• Leading improvement processes in production processes
• Leading validation processes for new products
• Execution of the works in accordance with ISO 13485
• IPC610 standard certification
• Handling customer and supplier complaints, opening, documenting, and following up customer and
supplier complaints
• Performing tests and leading the improvement of suppliers' quality
• Documentation of training and certification of employees
Monitoring of effective tests
• Knowledge of reading drawings
Work environment: Windows, Office, Outlook, ORACEL, VALOR
2016- “Zohar Dalia” , Quality Assurance -production of raw materials and intermediates for the detergent
industry and household and market cleaning products
• Handling customer and supplier complaints, opening, documenting, and following up customer and
supplier complaints in the MRP system
• Documenting training and monitoring effective tests
• ISO assessments and accompaniment
• Conducting internal audits in the various departments
• Monitoring the implementation of corrective actions and effective inspections in the areas of ensuring
quality, safety, and the environment
• Quality assurance tours in production and prevention of inconsistencies before packaging / delivery to
the customer
• Writing and updating procedures and work instructions
preparation of a management survey
Work environment: Windows, Office, Outlook, PRIORIT
2016-2011- Tosaf Compounds, Quality Assurance and TAPI- develops and manufactures additives,
compounds, and color masterbatches for the plastics industry
As part of my work, I gained experience in the fields of TAPI, and quality assurance
Quality Assurance:
• Handling customer and supplier complaints, opening, documenting, and following up customer and
supplier complaints in the MRP system
• Management of a safety and environmental plan
• Leading a set of safety committees
• Documenting training and monitoring effective tests
• ISO assessments and accompaniment
• Conducting internal audits in the various departments
• Monitoring the implementation of corrective actions and effective inspections in the areas of ensuring
quality, safety and the environment
• Writing and updating procedures and work instructions
• Preparation of a management survey
TAPI:
• Opening / closing work orders and placing them in machines
Monitoring the execution of a production plan
• Responsibility for recycling of GDP in future formulas
• Execution of production reports in the MRP system
Work environment: Windows, Office, Outlook, PRIORITY
Military Service
2006-2008- Graphic designer

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