Job Title – Quality Engineer Location – Cambridge Contract – 12 months Working pattern – Hybrid – Cambridge (2.5 days per week / 5 days per fortnight onsite)
SRG are working with a global leading pharmaceutical company that are seeking a Quality Engineer to join their busy team.
Lead design control and risk management activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures. Support and facilitation of effective risk management activities at external design companies and manufacturing facilities related to assigned projects. Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external. Provide input and support to design validation including, but not limited to, human factors engineering assessments. Support the assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures to support device development and supply. Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture. Support the generation of all regulatory submission data and content for assigned device projects. Support internal and external audits of the DCoE Quality Management System. BSc, MSc or PhD in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries 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. Device risk management expertise. Familiar with Human Factors Engineering – Usability Engineering. Understand project management methodologies and capable to provide technical leadership for projects. Thorough working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation. Capable of working independently with minimal supervision….