Quality Risk Manager (MD) (m/f)

REFERENZNUMMER:

311629/8

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Quality manager