Incoming Inspection & MRB Coordinator

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 Incoming Inspection & MRB Coordinator at ZOLL Itamar plays a pivotal role in ensuring the seamless flow of high-quality components for the WatchPAT family. In this position, you will be the central point of contact for operational quality, synchronizing activities between the warehouse, engineering, and external suppliers to maintain our rigorous FDA and ISO standards.

Essential Functions

Workflow coordinator: Define and manage daily priorities for incoming inspection to ensure alignment with production schedules.
Cross-Functional Bridge: Act as the primary liaison between Quality, Supply Chain, and Suppliers to resolve quality issues and streamline material approval.
Testing: conduct Inspection of the incoming good shipment according to Drawings and Specification.
MRB: Oversee the Material Review Board (MRB) process, ensuring timely disposition of non-conforming materials and driving closure of open items.
Suppliers: Communicate with key suppliers, including visits at supplier when needed
ERP Responsibility: Perform all inventory and quality transactions accurately within the company’s ERP system.
KPI Accountability: Ensure the department meets established targets for inspection turnaround time and accuracy.
Supplier visits

Required/Preferred Education and Experience

Practical Engineer, certified Technician or a related technical field. required
Certified Quality Auditor (CQA) or Certified Quality Inspector (CQI) or other Quality Certifications preferred
knowledge of ISO 13485 and FDA 21 CFR Part 820. (QMSR) preferred
At least 2-3 years of experience in Quality Control or Quality Assurance within a regulated industry (Medical Device, Pharma, Aerospace etc.)

Knowledge, Skills and Abilities

understanding of sampling plans (e.g., AQL), technical drawings, and the use of precision measuring tools.
Hands-on experience working with ERP systems (e.g., SAP, Oracle, or Priority), PLM (Product lifecycle management).
Ability to work independently, make firm quality decisions, and lead a team under pressure.

Preferred Languages

Hebrew - Expert
English - Intermediate

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Standing - Constantly
Walking - Constantly
Sitting - Occasionally
Lifting - Constantly
Carrying - Constantly
Pushing - Constantly
Pulling - Constantly
Talking - Occasionally
Hearing - Frequently
Repetitive Motions - Constantly
Eye/Hand/Foot Coordination - Constantly

Working Conditions

Extreme cold - Occasionally
Extreme heat - Occasionally
Humidity - Occasionally
Wet - Occasionally
Noise - Frequently

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.