Quality Risk Manager (MD) (m/f)

Bavaria  ‐ Onsite
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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
Start date
ASAP
Duration
6 MM
From
Hays AG
Published at
26.07.2016
Contact person:
Kerstin Werner
Project ID:
1173988
Contract type
Freelance
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