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 generation 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.