Quality Engineer

Itamar

At ZOLL, we're passionate about improving patient outcomes and helping save lives.

We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

ZOLL Itamar is an innovative medical device technology company that focuses on the development and manufacturing of Home Sleep Apnea Tests to aid in the diagnosis of respiratory sleep disorders. Our core product is the WatchPAT®️ family, a revolutionary FDA-cleared portable home sleep apnea test device, that is based on proprietary signal and analysis. 80% of patients who have sleep apnea are undiagnosed. We are committed to reach those undiagnosed patients and provide testing to promote wellness and enhance overall quality of life. WatchPAT®️ is commercially available within major markets including the U.S., Japan, and Europe, and is the leading home sleep apnea test in the US. ZOLL Itamar’s corporate headquarters, research and development and manufacturing are located in Israel with U.S. headquarters based in Atlanta, GA.

Job Type

Hybrid

Job Summary

We are seeking a dedicated and detail-oriented Quality Engineer to join our team. The Quality Engineer will play a critical role in ensuring that our medical devices meet all quality standards and regulatory requirements. The ideal candidate will have a strong background in quality assurance and control, with a focus on continuous improvement and compliance in the medical device industry.

Essential Functions

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• Knowledge of ISO 13485, FDA regulations, and other relevant standards and guidelines.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
• Proficiency in quality management tools.
• Certification in quality engineering (e.g., CQE, CQA) is a plus.
  
  

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• Knowledge of ISO 13485, FDA regulations, and other relevant standards and guidelines.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
• Proficiency in quality management tools.
• Certification in quality engineering (e.g., CQE, CQA) is a plus.
  
  

• Minimum of 3years of experience in quality engineering, preferably in the medical device industry.
• Proven experience with root cause analysis, and corrective/preventive actions