QA Specialist

Main responsibilities: 
Cooperating in the setting of quality objectives in the company processes 
Ensuring that the company’s quality system procedures and products are in compliance with the regulatory guidelines, regulations, and external standards 
Performing controls and verify quality in production processes and R&D via ECOs, Risk Management activities, internal auditing, and more. 
Ensuring validation processes are performed and documented. Review of applicable V&V protocols and reports. 
As applicable, open and handle CAPA’s, Nonconformance Reports including identification of the cause, root cause, correction, and corrective actions.  
Participate and prepare materials for Management Reviews. 
Participate in external regulatory audits conducted by the Notified Body. 
Conduct document control activities as needed. 
Conduct training in QA aspects as needed for the company’s employees.
Requirements and Skills: 
3-5 years of hands-on experience at a Quality Assurance department, in the Medical Device industry. 
High familiarization with ISO 13485:2016 requirements and interpretation of the Standard to practical and regulatory-complying processes and procedures. 
Knowledge in Design Control deliverables, change control process, and risk management methods. 
A Bachelor’s degree in a technical or scientific discipline is an advantage. 
Experience with quality management systems interactions and external NB audits 
Experience with R&D QA and with validation & verification  processes 
Familiar with quality management standards and methodologies. 
Fluent English & Hebrew, and writing proficiency. 
Excellent team player with good communication skills in multidisciplinary environments.