Contract position: A Quality Engineer is needed for a leader in innovative products and complete solutions in the healthcare industry in the Walpole, MA area. This position will be responsible for supporting various quality engineering activities. No per diem is available. Hours are from 8:00 AM - 5:00 PM.Responsibilities for the Quality Engineer
Requirements for the Quality Engineer
- Drive individual immunoassay Design History File (DHF) gap analysis and develop mitigation plan. Support Risk Management activities such as developing dFMEA and pFMEA.
- Support in development of Site Validation Master Plan. Create and develop individual qualification and validation protocol and report.
- Ensure that all qualification/validation plans, protocols and reports are complete, accurate and compliant with applicable requirements.
- Bachelor's degree and at least 5 years of experience in the medical device, biotechnology or pharmaceutical industry, with a Quality Engineer or Validation Engineer role.
- Experience in Design Control and risk management. Experience in the application of production and process controls including process validation.
- Health Insurance, and much more...
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.