Design Quality Engineer- 6 months contract
We are looking for a Design Development Engineer for initial 6 months project based in Switzerland. The project focus is to ensure that all development projects are in line with the new EU medical Devices Regulation and execute Global Plan strategy.
Responsibilities: • Enhance the Design Control and Risk Management processes
* Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes. • Conduct and lead design verification and validation activities. • Conduct and lead design / process failure mode effects and analysis. • Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Nonconforming Materials, Risk Management, etc. • Provide leadership in the understanding of medical device regulations to other disciplines. • Communicate effectively at all levels within Quality as well as cross functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing. • Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times. • Accountable for the successful delivery of multiple simultaneous projects, spanning multiple functional areas and locations. • Responsible of clear definition of project scope and deliverables, milestones and timeline, project risks and contingency plans. Requirements:
* A minimum of a Bachelor’s degree in Engineering or related technical or scientific discipline, • Working knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is required. • Previous Quality Engineering experience is preferred. • Experience in an Medical Device regulated environment
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.