Risk Management Specialist
vor 18 Stunden
At Thermo Fisher Scientific, we are seeking a highly skilled Risk Management professional to join our team in Freiburg. As a Risk Manager, you will play a critical role in ensuring the quality and safety of our products, particularly EliA products.
Key Responsibilities:
- Implement and coordinate Risk Management activities related to EliA products in Freiburg, in collaboration with other Quality Management members and departments.
- Develop and release Risk Management procedures, instructions, and forms.
- Provide training on the Risk Management process as needed.
- Support New Product Development, Product Care, and Compliance projects.
- Act as Chair of the IDD Risk Management Board, facilitating and supporting Risk Management meetings to evaluate risks and update risk files.
- Coordinate all Risk Management Process interfaces.
- Drive the ongoing Risk Management Remediation Project.
- Ensure 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 to 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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