Medical Device Design Control Expert – Quality Engineer NOVJP00024791 (m/f)

REFERENZNUMMER:

360711/11

IHRE AUFGABEN:

-Support technical activities within the development and commercialization of parenteral delivery systems, e.g. drug/device combination products and medical devices
-Ensure product compliance for the assigned projects
-Compile Design Control documentation and contributing to a high quality Design History File (DHF)
-Establish/participate in the documentation strategy
-Creation of applicable documents
-Support Life Cycle Management activities regarding changes in the DHF

IHRE QUALIFIKATIONEN:

-Master degree in Science/Engineering or Mechanical Engineering or university level engineering education
-Profound experience in a similar area
-DHF compilation, including Design Control process and other applicable regulatory, QA and GMP aspects
-Understanding of medical device regulations (FDA 21CFR 820 & CFR 4, EU Medical Device Directive)
-Experience in medical device quality assurance
-Background in mechanical engineering in general, product design/design for manufacture
-Good technical knowledge in primary containers, e.g. syringes and cartridge and auto injector device development, from early phase activities up to commercialization and production scale-up
-General understanding of pharmaceutical development
-General understanding of Human Factors Engineering and risk management
-Good communication and conflict solving skills
-Excellent skills in English language

WEITERE QUALIFIKATIONEN:

Project manager, Quality manager