Description
We are looking for a
Quality Risk Manager (MD) (m/f)
Reference: -en
Start: asap
Duration: 6 MM
Place: in Bavaria
Branch: Pharmazeutische Industrie
Your tasks:
- Responsible for medical device Risk Management through proactive Risk Management; update and maintenance of Risk Management related processes and tools
- Ensure Risk Management processes for medical devices according to ISO 14971 and IEC 62366
- Implement/harmonize/manage standard Risk Management system and tools for development, commercialization and life cycle management of medical devices
- Evaluation of risks associated with non-conforming products and evaluation of risk values for specific medical device defects
- Product assessments, medical device reporting and recall of activities per global standards and policies
- Responsible for all quality related risk evaluation processes starting from development (hazard analysis) to life cycle management (incident risk analysis)
- Ensure there are no supply interruptions due to issues associated with medical devices
- Evaluation of all non-conformities of marked products in regard to patient, compliance and business risk
- Assure periodic reporting of Risk Management KPIs for all MDs as part of Management Reporting process
Your qualifications
- Degree in Chemistry, Pharmacy, Microbiology or Biotechnology or another related science
- Profound experience in medical device Risk Management
- Fluency in English
- Very good German skills
- Ability to make sure no major or critical observations, which have not been identified through site quality risk management, impact business continuity
Skills:
- Quality manager
Keywords: Qualitätsmanager