Quality Engineer - Cambridge

Quality Engineer - CambridgeAtrium EMEA is looking for an accomplished Quality Engineer to join the Biotherapeutics Pharmaceutical RandD Centre in Cambridge, UK. You will provide design control and risk management subject matter expertise to medical device and combination product development programmes throughout the product lifecycle. This will involve generation and review of design history file and risk management file components whilst interacting with cross functional development teams at all levels of the organisation. 50% onsite work/ hybrid in Cambridge Essential:BSc in appropriate science and engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) Relevant experience in the pharmaceutical combination product and/or device industries or MSc in appropriate science and engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) Relevant experience in the pharmaceutical combination product and/or device industries OR PhD in appropriate science and engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline).History of working in accordance with the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.Experience in design ..... full job details .....