QA Engineer

About Inspira Technologies OXY B.H.N. Ltd.

Inspira Technologies is an innovative medical technology company in the respiratory treatment arena. The Company has developed a breakthrough Augmented Respiration Technology (INSPIRA™ ART500), targeting hyper-personalization care, supported by INSPIRA AI that is designed to rebalance patient oxygen saturation levels within minutes, aiming to significantly improve patient outcomes. This technology potentially allows patients to remain awake during treatment while reducing the need for highly invasive, risky, and costly mechanical ventilation systems that require intubation and medically induced coma.

Position Summary

We are looking for an experienced QA Engineer from the medical device industry to join our dynamic QA team. As a QA Engineer, you will be responsible for ensuring compliance with QMS procedures, following ISO 13485, and collaborating across departments to drive quality initiatives. If you find the role exciting and challenging, we want you on our team!

Requirements:

Responsibilities and authorities:

• QMS maintenance - manage document control, records control, CAPAs, NCs, equipment maintenance, employees’ competence,
  
  

• Support manufacturing activities.
• Perform suppliers’ audits.
• Manage suppliers’ authorizations and certifications.
• Support design control activities
• Support regulatory affairs activities.
• Participate in External and Internal quality audits.
  
  

• 3+ years experience as QA team member in the medical device field.
• Highly Knowledge of quality compliance standards, including all aspects of ISO 13485.
• Certified internal auditor
• Strong written and verbal communication skills in English.
• Ability to troubleshoot, identify root causes and systematically resolve problems.
• Must have strong organizational skills and an ability to handle track and execute multiple priorities.