QARA Engineer

Company Overview

Xstrahl is a leading medical technology company that designs and manufactures Medical X-ray Systems used in treatment of cancers and dermatological disorders, as well as a pioneer in the development of advanced X-ray systems for pre-clinical radiation biology research.

Job Overview

We are looking for a QARA Engineer who can work as part of the R&D team and support the team on design controls activities ensuring that the product development activities are in compliance with Xstrahl's Quality Management System's requirements..

The work would include creating and managing the design history files and technical files for the product (New Products and Design Changes).  The role will also support product regulatory submissions, product design transfer activities, CAPA analysis, and field corrections. 

Required Skills

1. Minimum Bachelor's Degree in Software Engineering, Computer Science, Electrical Engineering or any other engineering discipline
2. Minimum 3 years of experience in quality engineering role in medical device industry
3. Working knowledge of Medical Products Quality Management System
4. Experience in creating documentation for regulatory compliance (for example:  FDA, CE, etc)
5. Experience with design reviews and design controls
6. Working knowledge of CE certification requirements and transition from EU MDD to EU MDR
7. Good communication skills and ability to work seamlessly with cross-functional teams
8. Self-motivated and capable of working with minimum supervision

Desired Skills

1. Knowledge of statistical techniques (sampling plans, probability, etc)
2. Experience in regulatory requirements of countries beyond US and EU
3. Working knowledge with medical radiation products