Beschreibung
We are looking for a
Head of Medical Device Quality Compliance and System Manager (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Place: in Bavaria
Branch: Pharmazeutische Industrie
Your tasks:
- Accountable for the establishment, control and improvement of all quality systems/SOPs with regard to ISO 13485, 21 CFR 820 and CFR 4 for medical devices and combination products
- Ensure risk management processes for medical devices according to ISO 14971 and IEC 62366
- Accountable for the analysis and trending of relevant product and quality system data for management reporting and its coordination and mitigation in case of negative indicators
Your qualifications
- Degree in chemistry, pharmacy, microbiology or biotechnology or another related science
- Fluency in English in speaking and writing
- Experience in quality with focus on compliance and risk management of biopharmaceuticals drug products
Skills:
- Quality manager
Keywords: Qualitätsmanager