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.
- 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
- Direct QA/RA at start-up class III device company.
- Build quality system according to ISO13485 and QSR regulations.
- Manage a team of 3 QC technicians.
- Build Tech files, DHF, DMR and DHR.
- Perform validation including EtO, shelf life, and PQ.
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
- Set imaging protocols and carried out V&V tests.
Honors & Publications
- RvA Technical Expert
- BSI Lead Auditor
- Certified CE Auditor according to MDD 93/42/ECC (BSI Certificate)
- Certified Lead Auditor According to ISO 13485 (BSI Certificate)
- Certified Quality Manager
- M.S. Biomedical Engineering, Technion, Haifa, Israel
- B.S. Mechanical Engineering, Ben-Gurion University, Beer – Sheva, Israel