Director for our systems QA team (Verification and Validation)

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 Summary

We are seeking an experienced Director for our systems QA team (Verification and Validation) to lead Itamar's comprehensive testing efforts across software – primarily cloud, hardware, firmware, and mobile applications. As the Director, you will provide strategic leadership and oversight to ensure the quality, reliability, and regulatory compliance of our products through rigorous testing methodologies.

The position requires to work from the office at least three days a week across our Caesarea and Hertzliya locations.

Essential Functions

• Strategic Leadership - Develop and implement comprehensive quality assurance strategies for both software and hardware products.
• Team Management: Lead and mentor a team of QA engineers, fostering a culture of excellence, collaboration, and continuous improvement.
• Test Strategy Development: Define and oversee the execution of comprehensive test strategies encompassing functional testing, performance testing, usability testing, and more, utilizing both manual and automated testing approaches.
• Test Management Tools: Implement and utilize tools such as TestRail for test case management and reporting, ensuring effective test execution and traceability.
• Compliance: Ensure adherence to regulatory requirements throughout the process, including the preparation of documentation and submissions as required by FDA and other regulatory bodies.
• Cross-functional Collaboration: Collaborate closely with R&D, Quality Assurance, Regulatory Affairs, and Product teams to align on testing priorities, objectives, and timelines.
• Advantage - background in V&V position within the medical device industry
• Monitor and report on quality metrics, identifying trends and areas for improvement.

Required Education and Experience

• Bachelor’s degree in computer science, Engineering, or related technical field; advanced degree preferred.
• Minimum of 7 years of experience managing testing organizations in regulated industries, with a focus on both software and hardware products.

Knowledge, Skills and Abilities

• Experience in testing of cloud software, hardware, firmware, and mobile applications.
• Expertise in both manual and automated testing methodologies and tools (e.g., Selenium, Appium, JIRA, etc.).
• Experience with test management tools such as TestRail or similar for test case management and reporting. Strong leadership and people management skills, with a track record of building and leading high-performing teams.
• Experience in writing process documents like STD, STR, Test Plan and etc.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with stakeholders at all levels of the organization.
• Advantage – Experience in the medical world as V&V role and in-depth knowledge of regulatory standards and requirements (FDA, ISO 27001, etc.) pertaining to V&V.

Preferred Languages

• English - Advanced