QA/RA Consulting Project Manager

10/10/2021

תיאור

A Medical Devices Consulting company is looking for a QA/RA Consulting Project Manager

· Guiding and coaching our customers through the process of establishing, monitoring, coordinating and maintaining the company’s quality management system in order to meet established quality standards and release top of the line products.

דרישות התפקיד

· At least 3 years of experience in Medical Devices

· Knowledge of FDA Quality System requirements, ISO 13485:2016 requirements, 14971 requirements, Medical Device Regulation (MDR), Knowledge of Good Manufacturing Practices (GMP) and appl

icable Quality System Standards

· Knowledge of GDPR and HIPAA requirements – advantage

· Experience in SW as a Medical Device and related standards - advantage.

· Excellent English reading and writing

· Good communication skills, both verbal and written

· Detail oriented.

· Able to travel within Israel.

Qualifications

· BS/BA in engineering or science discipline.

· Certificate in quality assurance is a plus.