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:

Education:

• 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.