Design Control & Risk Expert - Medical Devices

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My client, a market leader in Medical Devices is recruiting for an experienced Design & Development Engineer who has had working experience in Design Control and Risk Management for medical devices.


* Working as part of a Design Quality team you will be focusing on life cycle management activities to enhance Design Control and Risk Management processes to drive continuous improvement.
* Establish test plans, evaluate data derived from statistical methods and design tools and perform Gage R&R studies• Conduct and lead design verification and validation activities.
* Conduct and lead FMEA and DFMEAs.
* Provide input and guidance within multiple areas of Quality Systems such as Corrective & Preventive Actions, Complaints, Nonconforming Materials, Risk Management, etc.
* Effectively manage channels of communication within different areas of Quality as well as cross functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing.


* A minimum of a Bachelor’s degree in Engineering or related technical or scientific discipline with a minimum of 7+ years of experience in related field is required.
* Working knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is required.
* Previous Quality engineering experience is preferred.
* Medical Device experience is necessary
* Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and design/process Failure Mode and Effects Analysis is preferred.
* Development and manufacturing experience is preferred

Kontakt: Luchele Mendes: +41 (0) 44 215 2051

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Tel: 020 7739 2022
Contact: Luchele Valentina Mendes

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