Our client, global medical device company has a new project available for a quality engineer to support the implementation of combination products and lead design transfer activities for assigned projects.
Your key responsibilities will include
• Lead design transfer activities • Collection and creation of design transfer documentation for consideration within the Design History File
• Development of control strategy and control plans from incoming inspection to product release testing.
• Creation of the Device Master Record
• Creation of Process FMEA in a cross functional team
• Collaborating with site operations, supporting any improvements to the processes and/or equipment,
• Support process and equipment qualification (IQ/OQ/PQ),
• A degree in Engineering and/or a scientific degree or equivalent combination of education and work experience.
• Experience in the medical devices field packaging or manufacturing or Research and Development (R&D).
• Broad scientific or engineering expertise with demonstrable results to deliver new products or sustain existing marketed products is required.
• Experience with FDA regulated Design Control, Change Control and ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purpose, European Medical Device Directive is required.
Fluent in English and German language is preferred
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.