Quality Engineer in Cambridge

54 Days Old

Energy Jobline is the largest and fastest growing global Energy Job Board and Energy Hub. We have an audience reach of over 7 million energy professionals, 400,000+ monthly advertised global energy and engineering jobs, and work with the leading energy companies worldwide.
We focus on the Oil & Gas, Renewables, Engineering, Power, and Nuclear markets as well as emerging technologies in EV, Battery, and Fusion. We are committed to ensuring that we offer the most exciting career opportunities from around the world for our jobseekers.
Job Title - Quality Engineer Location – Cambridge Contract - 12 months Working pattern - Hybrid - Cambridge (2.5 days per week / 5 days per fortnight onsite) Salary - PAYE - £16.77 p/h up to £25.98 p/h, Umbrella - £18.79 p/h up to £29.12 p/h SRG are working with a global pharmaceutical company that are seeking a Quality Engineer to join their busy team. Key responsibilities: 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 of all regulatory submission data and content for assigned device projects. Support internal and external audits of the DCoE Quality Management System. Identify, communicate, and develop strategies to improve combination product systems. Basic Qualifications: 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. Experience in design controls for combination products. Device risk management expertise. Familiar with Human Factors Engineering - Usability Engineering. Understand project management methodologies and capable to provide technical leadership for projects. Familiar with device assembling manufacturing processes. Thorough working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation. Working knowledge of 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.
If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
Apply
Location:
Cambridge
Job Type:
FullTime

We found some similar jobs based on your search