Quality Engineer - Cambridge

Quality Engineer - Cambridge

Atrium EMEA is looking for an accomplished Quality Engineer to join the Biotherapeutics Pharmaceutical R&D 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 life cycle. 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 & 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 & 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 & 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 controls and risk management for combination product
* Familiar with Human Factors Engineering - Usability Engineering.
* Familiar with device assembling manufacturing processes.
* Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
* Familiarity with EN 62366, EN 60601, and EN 62304.
* Able to learn and apply established procedures in a reliable and consistent manner.
* Capable of working independently with minimal supervision.
* High level of attention to technical details and accuracy.
* Able to prioritize multiple responsibilities and to work on multiple tasks simultaneously.
* Able to work collaboratively in cross functional teams.
* Excellent communication (eg, oral, written, presentation) and interpersonal relationship skills.
* Proficiency in general computer software such as word processing, spreadsheets, presentations.
* Understand Good Manufacturing Practices (GMP).

Click Apply now to be considered for the Quality Engineer - Cambridge role