Production 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
On Site

Job Summary
The Production Quality Engineer in Itamar will be responsible for quality production activities: monitoring production quality KPIs, planning and performing validations for processes and tools, failure investigations, writing and reviewing quality-related procedures, working with engineering and R&D on NPI processes.

Essential Functions

• Failure investigation in production together with engineering.
• KPI monitoring and reporting
• NCR, CAPA managing and Root Cause Analysis (RCA) in relevant cases Process
• Validation Planning, writing, and execution.
• Support R&D and Engineering in integrating new processes in production and in NPI.
• Follow up on production KPIs:
  Collect quality data from various sources.
  Analyze the data and determine the yield or first pass yield of Itamar Medical products, failures Pareto, failure trend and scrapped material cost etc.
  Collect data on SCARs and MRB and present various trends and KPIs.
  Preparing monthly and weekly quality presentations based on KPI follow up.
• SCAR monitoring: Monitor SCAR process and verify SCARs completion and effectiveness.
  MRB Monitoring: verify that there is no lag in MRB reporting and processing.

Required/Preferred Education and Experience

• Bachelor's Degree Electronic\Mechanical engineer required or
• Industrial Engineering or equivalent
• 3+ years of experience in multidisciplinary medical\pharma assembly\production lines engineering support. required and
• Production line problems solving experience required and
• Good knowledge in mechanical assemblies and PCBA’s manufacturing requirements. required and
• Experience with ERP and PLM systems – an advantage required and
• Medical Regulatory knowledge – an advantage required

Knowledge, Skills and Abilities

• Personal capabilities:
  Service orientation and independent work capabilities
• Fluent English, reading and writing English documents.

Preferred Languages

• Hebrew - Expert
• English - Advanced

Travel Requirements

• Centers in Caesarea

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.