Description
We are looking for a
Medical Design Control Expert - Quality Engineer (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Assist in technical activities within the development and commercialisation of parenteral delivery systems
- Continually using and understanding of medical device regulations FDA 21CFR 820 and EU medical device
- Prefilled syringe and auto injector device development from early phase activities up to scale-up
- DHF compilation, including design control process and other applicable regulatory (QA, QC and GMP aspects)
Your qualifications
- Background in mechanical engineering
- Experience in the field of verification, including development of methods and equipment
- Experience in medical device quality assurance
- General understanding of human factors engineering and risk management
- Profound English language skills
Skills:
- Quality manager
Keywords: Qualitätsmanager