Quality Assurance Manager

We are looking for a Quality Management Manager, for a medicine company dedicated to developing innovative tissue repair solutions that restore health and enhance patients' quality of life.

The company's leading product is already approved as a device with a CE mark in Europe, and the company is currently conducting a pivotal trial, under the FDA-sanctioned protocol, in the United States and Europe.

This is a full-time hybrid role, located in Herzliya with flexibility for mostly remote work.

Role Description

The Quality Management Manager will be responsible for overseeing all quality Management activities. The Quality Management Manager will work closely with cross-functional teams to ensure compliance with applicable regulations and standards, including ISO 13485 and FDA requirements. Day-to-day tasks include developing and maintaining quality management systems, performing audits, managing documentation, leading investigations, and ensuring all products meet quality specifications.

Qualifications 

* At least 5 years experience in a QA/RA position in the medical device industry, including ISO 13485 and FDA QSR  

* Bachelor’s degree in engineering, chemistry, or life science  

* Experience in regulatory activities in the US and Europe  

* Experience in NB audits

* Experience with Dekra - advantage   

* Experience in manufacturing processes in clean rooms  

* Experience with combination Products an advantage  

* Experience with Aseptic Processes an advantage  

* Attention to detail and ability to work independently  

* Fluent English