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