QA Engineer- 760

Our SME quality assurance group is looking for a new member! This is your opportunity to join quality assurance department at Medinol .

We love driven, self-motivated folks experienced in tech start-ups who thrive in fast-paced environments. Could you be our next hire?

Description

SME (Special Matter Expert) Quality group at a medical device company is looking for a Quality Leader who will be a content expert for quality issues required in the development and production stages of medical products.

The role includes supporting the initial development stages (C&F), advanced development stages (Design Validation and Verification), transferring the product from development to production up to its ongoing production while meeting international regulatory requirements.

Responsibilities:

• Leading the quality issues in the area of Development Life Cycle and manufacturing, including providing quality and regulatory emphasis in the Risk Management process
• Accompanying the teams in defining the testing arrangements for the product (Design Verification and Validation) and various validation processes (equipment, method, sterilization and cleaning validation).
• Support in leading process improvements and managing the implementation of changes throughout the development stages of the product and its transfer to production.
• Writing quality documents
• Approval of development and production documents

Requirements

• B.Sc., in the field of science - mandatory
• Previous significant experience in quality assurance roles in a development environment – mandatory
• Experience in a company manufacturing medical devices / pharma – mandatory
• Experience in validation processes (equipment and process).
• Knowledge in software validation processes - advantage
• Knowledge in design validation and post marketing surveillance - advantage
• Mastering International Standards, ISO 13485, FDA Guidelines, MDR
• English – high level
• Ability to drive processes and orientation towards results

About the company…

Medinol is dedicated to the science of cardiovascular intervention. For over 25 years, we have delivered over two million coronary stents to patients worldwide. Our products constantly stretch the limits of innovation and our cutting-edge technology continues to demonstrate extraordinary clinical results. We make our products in-house using proprietary manufacturing technologies that ensure consistently exceptional quality and safety. Medinol manufactures EluNIR™, the first elastomeric drug eluting stent. Now FDA approved and CE marked, EluNIR demonstrated excellent clinical outcomes and promising safety profile in two clinical studies and features the Flexx² catheter technology with a metallic spring-tip, resulting in unprecedented ease-of-delivery even in tough anatomies. A unique stent design provides low metal footprint and optimized vessel support, leveraged by an elastomeric coating that ensures excellent surface quality. Founded in 1992 by Dr. Judith Richter and Dr. Kobi Richter and privately held to this day, Medinol continues to benefit from the leadership and insight of its founders. With more than 300 employees on board, we proudly maintain our family spirit and entrepreneurial culture.