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