Quality & Regulation Engineer

Quality & Regulation Engineer

Job content:

Maintenance and control of the quality assurance system in the company

Writing and updating the company's procedures and relevant forms, including conducting trainings

Documentation of employee certification processes

Handling customer complaints - in coordination with relevant parties in the company

Responsibility for engineering change control (ECOs) in coordination with relevant parties in the company

Certification of suppliers, maintenance and updating of the company's approved supplier lists, including supplier inspections according to a predefined plan

Carrying out internal and external inspections according to a predetermined plan

Assistance with regulatory submissions

The position reports to the Regulatory Director

Full Time.

Sharon Area -Israel.

Background requirements:

Relevant academic education as an engineer/engineer in the field of quality engineering

Experience in quality assurance and regulation in a medical device company 3-5 years.

Work experience in a multidisciplinary company (hardware, software, systems and consumables, sterile products).

Familiarity with EU MDR, ISO 13485, ISO 14971, FDA QSR requirements - mandatory

Professional English

 Ability to work independently and manage priorities