Description
We are looking for a
Medical Device Design Control Expert – Quality engineer NOVJP (m/f)
Reference: -en
Start: 02/18
Duration: 6 MM++
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- 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
Your qualifications
- 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
Skills:
- Project manager
- Quality manager