Are you an experienced Quality Manager with strong knowledge of ISO 14971 and MDR? If so, Zenopa has the role for you!

Role - Quality Manager
Division - IV Therapy
Location -Berkshire

This is an exciting opportunity to join a true Global Leader in Medical Technology who are expanding their quality and risk management team.

In this role, you will take responsibility for:
- Providing leadership of the Risk Management Function for the company's products.
- Being accountable for the Compliance of risk management activities related to new product introduction (NPI) and to product maintenance for the infusion pump business.
- Driving Compliance and continuous improvement of risk management processes with the support of the MMS OUS Quality Engineering function.

The company are keen to speak to you if you have the following:
- Engineering degree in a technical field with a minimum of 5 years of relevant experience in the medical device industry
- Strong knowledge of Risk Management discipline and must be able to apply quality principles (GMPs, 21 CFR, EU MDR requirement, EN ISO 14971:2012, IEC 60601-1, ISO 13485, EN 62304, IEC 62366, FDA Guidance - Cyber Security, interoperability, assurance cases etc.) to the R&D environment.
- Must be able to apply quality principles (GMPs, 21 CFR, etc.) to the R&D environment.
- Demonstrates knowledge of risk management, regulatory and quality engineering policies, principles and best practices for medical devices

Please apply now to be considered for this exciting role!

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