South San Francisco
Employment Type: 
Job ID: 

Job Description:

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

Apply to this job

When applying to a Pro Source job posting, it is only necessary to apply one time to be considered for all open positions.

The following restrictions apply:
  • File extension must be: .doc .docx .pdf
  • Maximum file size: 10 megabytes