Quality Engineer

An exciting new contract has become available for a Quality Engineer in a market leading medical device company. Candidate's responsibilities will be to manage and support the companies' two new devices. The client requires the candidate to have an understanding of the ISO 60601 directive.

Validation Engineer Responsibilities will be

* Provide technical support within the validation life-cycle including new equipment introduction, process improvement programmes, and engineering changes to include documentation
* Generation and independent review of validation lifecycle deliverables and documentation as required to ensure compliance with regulatory authorities and fitness for purpose of business systems and equipment (this may require execution of protocols)
* Providing support for the control of non-conforming product/systems and CAPA to ensure compliance and continuous improvement of the business
* Provide support for risk management activities to ensure compliance and continuous improvement of the business
* Ensure compliance with ISO 13485:2003 & ISO 60601 and other International Regulatory requirements.
* This role reports to a Technical and Manufacturing Manager and provides validation expertise and plays a lead role in driving equipment and process validation improvement initiatives.
* Working alongside Software Engineer, developing & validating the product.

Validation Engineer Requirements;

* Understanding of and experience in the following subsections; DQ, CQ, IQ,OQ,PQ
* Validation expereince within a Medical Device company is a must
* Technical writing expereince
* Use of statistical techniques for data analysis
* Ability to follow project management plans
* Expereince in final risk management, management of datasheets & testing
* ISO 13485 & ISO 60601

Should you wish to apply for this position then please feel free to contact me as on or contact me on 0207 758 7322.

Keywords: Validation Engineer, Validate, Validation, Quality Systems, Technical Writing, ISO 13485:2003, ISO 60601, FDA 21 CFR Part 820, DQ, CQ, IQ,OQ,PQ,

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