IceCure Medical, an innovative and fast-growing medical device company and leader in the Cryoablation market, is looking for a Quality Engineer to join the Quality Assurance, Regulatory Affairs and Clinical department in Caesarea, Israel.

The Quality Engineer will report to the Quality Assurance Director. 

Job description:


  • Collaborating with Operations, QA, Engineering and Manufacturing and CMs functions to ensure quality standards are in high level
  • Leading manufacturing transfer quality engineering activities
  • Maintaining and control of QMS under ISO 13485 and MDR
  • Representing Quality in the project core team
  • Supporting day-to-day manufacturing activities performed in house and at CMs.
  • Leading manufacturing quality escalations to resolution.
  • Taking an active role in leading, reviewing and approving design and manufacturing changes.
  • Leading product quality investigations in support of CAPA, complaints and non-conforming material processes.
  • Collecting, analyzing and interpreting statistical data, performing analyses and providing reports as required.
  • Leading Quality Assurance and product quality improvements for cross functional initiatives.
  • Controlling suppliers quality, performing suppliers audits and suppliers CAPA.
  • Training of employees and maintaining training documentation.


Education and experience:

  • Bachelor’s degree in mechanical, biotechnology, bio-medical, industrial or similar engineering disciplines.
  • 3-5 years experience in Quality Assurance, at a multidisciplinary Medical Device Company.
  • Certified Quality Engineer (CQE) or other similar quality/reliability certifications – Advantage.
  • Familiarity with medical device regulations (ISO, EU, CFR).
  • Strong understanding of product lifecycle process
  • Good Communication skills both verbally and in writing
  • Good analytical skills
  • High ability to work independently
  • Self-motivated and proactive
  • Fluent in English with excellent writing skills
  • Excellent computer skills, including a working knowledge of Microsoft Office applications.