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.

Responsibilities:

* 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.

Requirements:

* 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.