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

Technical Consultant #2541


Expertise

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.

Experience

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


Credentials

  • 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

Languages

  • English 

Education

  • M.S.   Biomedical Engineering, Technion, Haifa, Israel
  • B.S.   Mechanical Engineering, Ben-Gurion University, Beer – Sheva, Israel
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