Job Information
Zoll Medical Corporation Quality Engineer in IL Caesarea, Israel
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 TypeHybrid
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.
Duties and responsibilities
Lead and participate in root cause analysis and corrective action investigations for product and process issues. (CAPA)
Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality considerations are integrated into product development and production processes.
Develop and maintain documentation, including quality plans, instructions, and procedures.
Monitor and analyse quality performance metrics and trends.
Provide training and support to staff on quality standards, procedures, and best practices.
Participate is Design reviewed and risk assessment strategies for new and existing products.
Review and approve V&V Protocols and Plans
Required/Preferred Education and Experience
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.
Position Requirements
Minimum of 3years of experience in quality engineering, preferably in the medical device industry.
Proven experience with root cause analysis, and corrective/preventive actions
ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.