QA Director

A high-tech company developing and manufacturing an innovative medical device designed for real-time monitoring in hospitals, specifically for operating rooms and intensive care units. The product is multi-disciplinary and provides critical medical information about patients in real-time.

The company has paying customers, and the product is already sold in Israel and the U.S., with plans to expand to additional countries soon.

The company is located in Modi’in, was established in 2018, employs 40 people, and offers stock options to employees.

Role Overview:

• Lead and manage the entire QA domain in the company, ensuring strict adherence to regulatory and quality standards for medical devices.
• Work in a small team with significant hands-on involvement.
• Oversee internal and external audits, manage CAPA processes, handle customer complaints, and provide solutions.
• Act as the company’s PRRC (Person Responsible for Regulatory Compliance), monitor market activities, fulfill reporting obligations, and assess compliance.

Requirements-

• Master’s degree or equivalent in a relevant field, with 8+ years of experience in quality assurance/control, including leadership roles within the medical device or diagnostics industry.
• In-depth knowledge of MDSAP, MDR, ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations.
• Master’s degree or equivalent in a relevant field, with 8+ years of experience in quality assurance/control, including leadership roles within the medical device or diagnostics industry.
• In-depth knowledge of MDSAP, MDR, ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations.