Job Summary
A staffing company is filling a position for a Telecommuting Quality Engineer.
Individual must be able to fulfill the following responsibilities:
- Provide Quality Assurance support to sites as needed
- Support marketed product changes and updates MOB
- Drive test strategies meeting right first time expectations
Skills and Requirements Include:
- Three years of experience in Medical Device and/or Pharmaceutical Industry in Quality, R D, Engineering or Laboratory environment
- Bachelor's Degree BS in engineering or scientific discipline Chemistry, Biology, Microbiology
- Three years developing and implementing product requirements in compliance with US federal and international regulatory standards relating to medical devices
- One year utilizing corrective and preventive action CAPA system that is in compliance with US federal and international regulatory standards relating to medical devices
- One year risk analysis experience
- One year Complaint management, complaint review and corrective action.One year Utilization of root cause analysis tools, including fault tree analysis, 5 Whys, Is/Is Not,
