South San Francisco
Works independently and provides oversight of device quality engineering activities during product development.
Be the responsible quality oversight during device development.Job Responsibilities:
- 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 activities
- 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 projects
- 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