Medical Device Technical Expert - Risk Management (m/f)

REFERENZNUMMER:

291377/2

IHRE AUFGABEN:

-Lead specific risk management activities within projects as agreed with project leaders
-Facilitate development and completion of risk assessments
-Ensure timely completion and quality of the assigned risk management files
-Manage the overall risk management program of the packaging and device development activities within the team
-Ensure compliance with ISO 14971 in all development projects
-Supervise risk management activities in all development projects
-Harmonize the medical device risk management outputs across all development projects
-Conduct and provide guidance on the use of risk analysis for use, products, components and processes
-Ensure compliance with regulatory and normative guidelines, focusing on medical device risk management
-Work with device development team to incorporate and complete risk management during all design phases for new and/or product enhancements
-Apply FDA CFR 820, ISO13485 and ISO 14971 risk management in assigned projects

IHRE QUALIFIKATIONEN:

-Master degree in Science/Engineering or Mechanical Engineering or University level Engineering education
-Excellent English skills are required
-Proficiency in German is advantageous
-Other language skills, e.g. French, are also advantageous
-Experience as medical device risk management team leader
-Experience in managing risk management files
-Good technical knowledge of parenteral packaging and medical devices
-Awareness of Human Factors Engineering
-Experience in development and documentation of drug/device combination products and medical devices, including Design Control process and other applicable regulatory, QA and GMP aspects

WEITERE QUALIFIKATIONEN:

Quality manager, R&D scientist