iceCure Medical, an innovative and fast-growing medical device company and leader in the Cryoablation market, is looking for a QA/RA Eng to join our team in Caesarea, Israel.

Position requirements:


  • Regulatory or Quality Studies, Engineering or similar profile
  • More than 5 years of experience in regulatory and quality assurance implementation.

Former experience in the following:

  • Working in Medical Device: Initiate, monitor, and verify the effective implementation of the Quality Management System in all areas of company activities
  • Regulatory submissions: Regulations requirements of the ISO 13485; FDA; CE (MDD/MDR) and MEDDEV
  • Composing and maintaining quality manual procedures (i.e., SOP’s), Follow the requirements of GLP/GMP.
  • Internal and external audits, inspections.

The following skills and abilities are advantageous:

  • Computer skills with ERP (Priority) and ALM (Orcanos) systems.
  • Fluently verbal and written English.
  • Able to quickly learn and apply new concepts.
  • High ability to work independently.
  • Self-motivated and proactive.
  • Planning, organizational and administrative abilities.
  • Good interpersonal skills.
  • Technical skills.

Job description:

Quality Assurance

Implementation and management of all QA activities which includes:

  • Quality System Tools administration, training and auditing [as Customer Complaints/CAPA/Training/Control Documents/Standards].
  • Verify the compliance of quality procedures and working instructions with predefined and new mandatory standards.
  • Ensure that the Company’s quality assurance and control system complies with the procedures and working instructions through audits, training, preventive and corrective actions.
  • Maintaining the training, qualification, and certification records of Company personnel including developing, determine and conduct training and certification subject to the Quality Manual.
  • Approve / disapprove suppliers and vendors of goods and services subjected to the Quality Manual.
  • Approve / disapprove facilities, equipment, processes, and materials subjected to the Quality Manual.

Regulatory Affairs:

  • Regulatory submissions in various countries.
  • Regulations requirements support to all areas of company activities.
  • Define and conduct tests, bench tests and experiments to support regulatory requirements.
  • Marketing, Social media material and labeling review & approval.
  • Report to QA Director.