Works independently and provides oversight of device quality engineering activities
during product development. Be the responsible quality oversight during device
* Provide quality oversight for the Design History File and Risk Management File
according to Design Control and Risk Management processes
*Perform any other tasks as requested by Management to support Quality oversight
* Notify Management of potential quality or regulatory issues that may affect product
quality or regulatory compliance.
* Experience leading and working with internal and external teams through end-to-end
* Able to educate teams and organization on Design Controls and related topics
* Demonstrated capability of ISO13485, 21CFR820 and ISO14971
* Demonstrated capability of applying risk management concepts and tools *
Understanding of the biotechnology industry and specifically combination products.
* Well developed teamwork and collaboration skills and ability to communicate clearly
and professionally both verbally and in writing.
* 12+ years experience in a Device Development and/or Device Quality Engineering
role for a medical device and / or pharmaceutical company