Cpl Life Sciences are looking to recruit a Quality Engineer to join a global Pharmaceutical organisation based in Cambridge. This role sits within their combination product team - combination product or medical device experience are highly desirable.
This role will provide design control and risk management expertise to medical device and combination product development projects, from initial design through to manufacturing. This role heavily involves generation and review of DHF/risk management files, working alongside device development leads, design engineers and human factors SME's.
This role is a PAYE contract - 12m You will be expected to be present at the Cambridge site (average of 2.5 days per week/5 days per fortnight).
Responsibilities include:
* Lead risk management (ISO 14971) and design control activities.
* Ensure product development activities are compliant with quality and regulatory standards.
* Provide support to design validation/human factors engineering teams.
* Support design and manufacturing investigations.
* Support internal and external audits from a product development engineering stance.
Skills and qualifications:
* BSc in appropriate science & engineering discipline with a minimum of 5 years of relevant experience in the pharmaceutical combination product and/or device industries
* Knowledge of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
* Ideally experience in design controls for combination products.
* Familiar with Human Factors Engineering - Usability Engineering.
* Familiar with medical device manufacturing processes.
If interested, please apply directly or email your CV to megan.smyth@cpl.com