Design Quality Assurance Manager (m/f)

REFERENZNUMMER:

267831/11

IHRE AUFGABEN:

-Provide active support and guidance to project teams to ensure compliance with Design Control procedures during the development of new products and the product lifecycle
-Review and approval of technical documentation
-Provide proactive guidance on how to appropriately adapt projects and processes to specific needs
-Support of project teams to avoid nonconformance and managing necessary process deviations within the constraints of the Quality Management System (QMS)
-Provide guidance and advice to process owners and managers on how to define, establish and maintain processes in accordance with applicable requirements (regulations, standards, procedures etc.)

IHRE QUALIFIKATIONEN:

-Studies in natural or applied science, engineering, or education and training with relevant work experience in a related technical field (required)
-Training in QMS Standards and Regulations, including but not limited to ISO 13485, 21 CFR 820 and ISO 14971 (pertinent certification preferred)
-Training, work experience or proven skills in the areas of medical device software lifecycle (EN 62304), usability engineering (EN 62366) or safety testing (IEC 60601-1) standards (strong advantage)
-Knowledge and experience in systems engineering or development of medical device software (highly desirable)
-Excellent written and verbal communication skills including fluency in English (required) and German (preferred)
-A flexible and team-oriented personality with professional communication skills, the ability to assert oneself and to work under pressure in a fast-paced international environment

WEITERE QUALIFIKATIONEN:

Quality manager