QA Engineer - 778

QA Engineer

Our SME quality assurance group is looking for a new member! This is your opportunity to take part and make a real impact, supporting the development processes of cutting-edge medical devices.

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 R&D 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