Senior Quality Manager
We are looking to recruit an experienced Quality Manager to join the Quality Management & Regulatory Affairs team at a client of ours in Munich. Our client is delivering patient care through their digital mobile app with well over 1million users across Europe.
+ Ensure measures are in place to allow a high level of consistency of all regulatory processes
+ Maintain an agile approach while ensuring all medical device related processes comply to ISO13485 and other Quality standards
+ Manage and refine the ISO 13485 compliant QMS & RMS
+ Implement internal improvement processes including internal audits, CAPA or non-conformity management
+ Experienced working within a QM role within the medical device space, with a strong understanding of the latest EU and FDA regulations
+ Experienced with ISO standards for Quality - IEC 62304, AAMI TIR45, and risk management - ISO14971
+ Work experience within a 'software as a medical device' environment would be an advantage
+ Experienced optimizing existing processes and authoring lean process descriptions that align with the business
For an initial conversation about this opportunity please apply below or email directly to email@example.com and we will be in touch to discuss your suitability.