Quality Control Specialist

24 hours ago


Cambridge, Cambridgeshire, United Kingdom Russell Tobin Full time

Join Russell Tobin in Cambridge, UK as a Quality Control Specialist.

Job Description

We are seeking an experienced professional to 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.

The successful candidate will 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. This includes supporting and facilitating effective risk management activities at external design companies and manufacturing facilities related to assigned projects.

We require the successful candidate to ensure combination product development activities are compliant with quality and regulatory standards, both internal and external. This includes providing input and support to design validation including, but not limited to, human factors engineering assessments.

A BSc/MSc/PhD degree in an appropriate science & engineering discipline is required along with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries. The ideal candidate will have working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.

A competitive estimated salary is £25,000 - £35,000 per annum, depending on experience.



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