Bio-Medical & Mechanical Engineer: Medical Devices, Quality Systems, ISO, QSR, CFR Requirements, CE Certifications, R&D & Manufacture

Technical Consultant #2541

Assurance, Quality Control, and Regulatory Affairs

Manage and establish total quality system according to EN ISO 13485:2016, MDD/MDR Requirements and QSR (21 CFR 820).
CE ( European Certification) certificated from technical documentation preparation through submission and external audit by notified bodies.
Other countries certificates: Japan (including on-site audit), Korea, Canada, Australia, India with special requirements of different countries in Europe.
Submission to the Israeli Ministry of Health (AMAR).
Safety tests products according to standards EN IEC 60601-1, IEC 60601-1-2 and biocompatibility according EN ISO 10993.

Research and Development Quality Phase

Author and document development: Requirements, Specification, Risk Analysis etc.
Author and perform V&V tests, Process Validation, Sterilization Validation etc.
Building Design History File (DHF) according to FDA requirements.
Write Software documents according to Software Life Cycle standards.
Write and perform design verification protocols, (EMC, Safety, Fatigue, and Performance).
Write and define transfer from development to production procedures.

Manufacturing Quality

Provide suppliers and subcontractors’ audits and monitoring.
Preparation of DMR and DHR.
Treatment of failures and CAPA opening.
Establish quality systems at subcontractors (China), including training, supervising and implementation.
Oversee clean rooms and sterilization procedures.
Transfer to Production (TTP) implementation.
Experienced of managing team of QC Technicians / Quality Engineers / Quality Laboratory staff.

S.Q.A. Founder & CEO, 2016 – Present

BSI Lead Auditor and RvA Technical Expert 2018 – Present

Provide professional quality assurance and regulatory affairs services for the medical device industry.
Manage a team of several QA engineers.
Building and implementing quality management systems and providing regulatory services; helping R&D and production departments in building the DHF, DMR, DHR binders; Simulate external ISO13485 audits and run courses and training.

QA/RA Freelance Consultant, 2009 – 2016

Work with several medical companies, helping in their ISO13485/21CFR820 implementation and yearly ISO13485/CE audits.
Write Tech files and perform submissions to CE and 510k.
Write DHF/DMR/DHR binders including process validation and SW, (Software) life cycle documents, perform design verification (EMC, Safety, performance, Gamma, EtO, mechanical and functional).

Cardiapex, Israel, QA/RA Director, 2011 - 2014

Common Sense LTD, Israel, QA/RA Director, 2009 - 2011

Maintaining ISO13485 and CE approvals, CE/510k submission for new products, regulatory submissions, servicing countries (Japan, Korea, India etc..), for this a medical device company (IVD).
Maintain compliance with clean rooms requirements.
Responsible for the quality transition from development to production in China.
Responsible of QA engineer and two QCs.
Responsible of customers' complaints, recalls, and contact with competent authorities and notified bodies.

Ortho-Kinemtica, Israel, QA/RA Director, 2007 - 2009

Direct QA/RA a start-up company that developed a neck implant.
Establish quality system-related documents and performed V&V (verification and Validation) test (sterilization, shelf life, fatigue, etc.).

Deep Breeze, Israel, System Manager, 2004 - 2007

Manager at company that developed lung imaging device.
Responsible for QA at R&D and Production.
Manage team of 3 technician and quality engineers.
Responsible of design verification including EMC, Safety, mechanical performance, and SW (Software) validation.

GE Medical System, Israel – MRI Division, System Engineer, 2001 - 2003

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