Innovative Medical Devices - Risk Management [Switzerland]

 

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Support R&D with Risk Assessment

Ready to work with a service provider and on site manufacturer of medical devices for pharma dosage solutions?
ISO 14971 is an international standard that provides guidance in establishing a risk management system for medical devices throughout the lifecycle.

Continuous innovation and product development helps our customer to stay ahead of the competition and attract international customers. Adapt quickly to changing customer preferences, technological advancements, and emerging markets.With this business sense you play an important role to help our customer thrive.

Be the risk interface in Development - Patient Feedback and Product Risks! At this point you are the liaison between incidents that influence the ongoing product improvement and the corresponding technical documents.

Your tasks:

• Establish the criteria for risk acceptability and determining the methods and tools to be used
• In Risk Analysis you identify potential hazards associated with the medical device
• You evaluate the identified risks based on the established criteria for risk acceptability
• You are responsible that risk control measures are implemented to mitigate or eliminate identified risks.
• These measures can include design modifications, protective mechanisms, safety labeling, training, or establishing safety guidelines for device use. The effectiveness of these measures should be verified and validated.

International standards such as ISO 13'485 or other regulated environments such as GMP do play a significant role in the documentation and application processes.

\_\_Your profile:

• Training in technology (microtechnology, electronics, software, control technology) or natural sciences
• Knowledge of process analysis, feature analysis, risk analysis
• Experience of working in a regulated environment
• Experience with risk analysis and risk project management ISO 14'971
• Good knowledge of English, some German is an asset.

You are a creative thinker, able to analyse data, processes and product use and contribute with ideas and viable suggestions.
Interested? We are looking forward to get in touch with you.
Online application\_\_

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