QUALITY ASSURANCE/ REGULATORY AFFAIRS ENGINEER
ICECURE JOB DESCRIPTION
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.
- 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.
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 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.