Description
We are looking for a
Senior Quality Systems Manager and Notified Body Account Representative (m/f)
Reference: -en
Start: 07/16
Duration: 18 MM
Place: in Hesse
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Responsible for QM-Systems of Quality Management
- Responsible divisional key contact for corporate notified body regarding ISO 13485 and MDD certification including creation of divisional change notifications and review of local change notifications
- Global internal audits according to ISO 9001, ISO 13485, MDD and 21 CFR 820 of FK organisations
- Project lead for quality management projects
Your qualifications
- Experience with notified bodies and CE marking of medical devices
- Experience as a Medical Device Quality Auditor according to ISO 9001, ISO 13485, MDD and 21 CFR 820
- Knowledge of international medical device regulations
- Proficiency in design and maintenance of quality systems
- Fluency in English and German
Skills:
- Quality manager
Keywords: Qualitätsmanager