QUALITY
MANAGEMENT
& REGULATORY
Yuval Shapiro, B.Sc., M.Sc., MBA
Medical Devices | Telecom | Production | EMS
SERVICES
Management Systems according to ISO13485: 2016, EU - MDD/MDR, 21CFR820, ISO9001: 2015, ISO27001, ISO14001 & ISO45001: 2018 (OHSAS18001)
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Establishment and implementation of QA, Regulatory, Environmental and Safety programs
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Documentation of work processes in procedures and work instructions
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Organizational measurements - KPI
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Internal quality audits
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Preparing and representing the organization toward third party quality audits
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Risk management programs: mapping, evaluation, provision of medicines and their timing
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Quality management surveys
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Management of corrective and preventive actions – CAPA
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Training
Management Systems
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Regulations and standards - mapping the regulations and devices that the product under development is required to comply with
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Supporting the Project Manager in its implementation - PMO
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Development folder management (DHF)
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Risk Management (FMEA)
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Product verification strategy
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DOE – Design of Experiment
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Reliability calculations
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Support for environmental experiments
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Training
Design & Development Quality
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Engineering change management
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Documentation change management
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Device Master Records
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Transition from development to production: Preparation of work instructions for production and testing
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Adverse events investigation
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Safety tests support (IEC60601, UL, etc.)
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Validation of production processes - Production Process Validation
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Improving production processes 6Sigma / 5S
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Corrective and Preventive Actions - CAPA
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Supplier quality: evaluation, control, and handling of SCAR complaints
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Statistical analysis
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Training
Engineering & Production Quality
ABOUT
Quality Assurance & Regulatory Affairs Expert for products and companies primarily related to medical devices and telecom that meet the real needs of their clientele. Substantial experience gained in various multi-discipline technology industries (Military, Telecom & Medical Devices), and give a high-value contribution to quality and reliability projects related to the medical device and telecom industries.
More than 20 years of experience in QA; including MD&D RA & QA (EU-MDD/MDR, 510k);QMS (21CFR - Part820, ISO13485, TL9000, CMDCAS, ISO9001). EH&S Systems; QA/RA representative in R&D Projects; Risk Analysis as per ISO14791& ISO31000; EMC & Safety Certifications
Supply Chain QA & Supplier QA; CAPA; Training; Six Sigma; Process Validation; 5S and Lean Production; Configuration Control.
Credo אֲנִי מַאֲמִין
"Quality is Free; it cost money, but it pays itself"
(P. Crosby)
Production Lines
Transfer
Engineering
Process Validation
Projects
