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QA Engineer

Job Description

Basic Job Purpose: Lead quality processes & activities in a line of products.

In his roll he will cover all quality aspects related to: design control, supplier control, customer complaints investigation, process control and improvement (CAPA’S) , data collection and analysis


Main Duties:

  • Supporting  all quality activities in products design process / design control – development plan , Design reviews , ,product Risk analysis , Products verification & validation protocols verification , transfer to production 
  • Leading the quality activities with subcontractors as- new supplier qualifications and evaluation, supplier’s complaints handling incoming inspections, quality agreements, and quality sessions
  • Data collection and analyzing – periodic reports and trend analysis
  • Product final release activities
  • Leading field events / Customer complaints investigation 
  • Involve in quality processes improvements

Requirements

  • BSc in Electrical / Reliability Engineering
  • Quality education – CQM or CQE. Or Master’s degree
  • At least three years of experience in a similar role
  • Experience with:
    • Approving design reviews
    • Writing testing and approving protocols
    • Test planning and V&V tests
    • Knowledge in Process Validation, PRR, PFMEA
  • Familiar very well with product Life Cycle method’s and control, medical standards /regulations and general standards knowledge (for example :  ISO13485 , FDA – QSR , MDD, IEC 60601, etc.’)
  • Familiar with Failure analysis and statistic techniques methods and Expertise
  • Multi-tasking and objective dedication
  • Good interpersonal relationship

Information

Job Number:
1B.20F
Job Category:
QA
Job Type:
Full-time
Area:
YokneamIL
Published:
4/19/2017
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Lumenis is a world leader in laser- and light-based technologies for medical and aesthetic applications. Ever since introducing the first medical laser system in the world nearly 45 years ago, Lumenis has been at the forefront of technological innovation and market leadership in its segment. Today, Lumenis offers a wide range of products, an unparalleled technical support system, the largest global installed-base of medical laser products and one of the largest investments in research and development in the industry. Lumenis has installed more than 60,000 medical systems in doctors’ offices, clinics and operating rooms in more than 75 countries around the world. The company has over 100 FDA clearances; more than 250 registered patents & patent applications; and a team of more than 1000 employees that work in synergy worldwide. Further, Lumenis is a truly an international organization, with direct business offices in strategic locations around the world, including the United States, UK, Germany, Italy, Israel, China, Hong Kong, India, Japan and Australia. Lumenis Ltd. Is located in Yokneam, and includes 350 people (HQ functions, Products, Operations, Regulation, etc.).

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