Validation Engineer

The Validation Engineer is responsible for interfacing with both internal and external customers to facilitate the implementation of process controls and validations for 3D printing platforms as regulated by the ISO 13485, AS9100, ISO 9001 and global requirements such as FDA QSR, MDD and various aerospace regulations. This position is responsible for supporting the development and execution of manufacturing processes and quality systems in accordance with internal guidelines as well as customer driven requirements.

In this job, you will not only cooperate with your service and application engineering colleagues world-wide, but you can also rely on the knowledge and experience of colleagues from other 3D Systems divisions. Responsibilities:

• Collaboration with project teams, including both internal and external stakeholders, as a contributing member by providing quality and process engineering support in the development of new products and processes using 3D Systems’ products • Application and process development of new technologies to enhance the capabilities of 3D Systems • Contributing to the development and execution of verification & validation plans, testing, and generation of test protocols and reports • Coordination and execution of process qualifications inclusive of IQ, OQ, and PQ both internal as for customers • Development of and contribution to the risk management process • Development of and contribution to process controls and planning • Participating in the compilation and review of technical documentation for both domestic and international regulatory submissions • Assisting project teams on compliance with design control requirements per EN/AS9100, EASA/FAA, FDA QSR, European MDR, ISO 13485/9001 and other applicable ISO/EN standards • Participating in the execution, maintenance and improvement of the Quality Management System

Master

Biomedical Engineering, Chemical Engineering, Mechanical Engineering

Sector

Aerospace

Location

Flemish Brabant

City

Leuven

Benefits

• A challenging job in a young and dynamic team • A competitive salary and additional non-statutory benefits • Career opportunities in a global company with exponential growth

Wanted Profile

• Bachelor’ or Master’s degree in engineering or science; and/or equivalent by experience • 3-5 years of related work experience in regulated, cGMP environment such as medical device, pharmaceutical or aerospace manufacture • A strong commitment to providing excellent customer service • Experience with Additive Manufacturing is a plus • Quality assurance and reliability experience supporting product development and/or manufacturing are preferred • Working knowledge of GMP and EN/AS9100 / ISO 13485 Quality System preferred

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