Risk Management Specialist

vor 4 Wochen


Freiburg, Baden-Württemberg, Deutschland Thermo Fisher Scientific Vollzeit
Job Summary:

We are seeking a highly skilled Risk Management Specialist to join our team at Thermo Fisher Scientific Inc. The successful candidate will be responsible for initiating, coordinating, and monitoring all Risk Management activities related to EliA products in Freiburg, in collaboration with other QM members and departments.

Key Responsibilities:

• Implement ISO 14971 standards
• Release all Risk Management procedures, instructions, and forms
• Train the Risk Management process as needed
• Support New Product Development, Product Care, and Compliance projects
• Support all activities where risk management is needed (CAPA, NCs, validation, QMS)
• Act as Chair of the IDD Risk Management Board: Facilitate/Risk Management meetings to evaluate risks and update risk files; Represent the CoE Autoimmunity and coordinate all RM related projects for Freiburg in the ImmunoDiagnostics Division (IDD)
• Coordinate all Risk Management Process interfaces
• Drive the ongoing Risk Management Remediation Project
• Risk Management Reporting

Requirements:

• University degree in natural or pharmaceutical science (health science, biology, biochemistry area) with relevant professional experience
• Strong theoretical and practical knowledge in Risk Management (ISO 14971)
• Good Quality management background (ISO 13485, QSR, MDR, IVDR)
• Many years of experience in production within Medical Devices, IVD, or Pharma environment
• People management, communication, and problem-solving skills
• Experienced in Project Management
• Independent and well-structured approach of tasks
• Excellent spoken and written language skills in German and English
• Auditor certification is a plus

What We Offer:

• Employment with an innovative, future-oriented organization
• Outstanding career and development prospects
• Company pension scheme and other fringe benefits
• Exciting company culture which stands for integrity, intensity, involvement, and innovation

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