|Job Ref:||204469583||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Permanent||Country:||United Kingdom||County/State:||London||City:||Greater London||Address:||Salary:||£45000 - £52000/annum Private health, pension||Post Date:||10/10/2016 18:48|
High Technology manufacturer of scientific instrumentation
An excellent opportunity exists for a Quality Engineer to support the design and development of new products and the Quality System to ensure delivery of the highest quality product to the customer. Specifically to drive and support functional owners to achieve effective use of risk management processes through the use of FMEA, and mistake proofing in product, and process design. Effect quality assurance initiatives to achieve Quality System compliance, product quality and reliability with focus on design. Support functional owners to achieve effective design verification and validation results to meet regulatory requirements, and to achieve effective us of technical and formal design reviews for product designs. Manage the quality of incoming parts for prototyping. Develop, implement and maintain Quality and Regulatory Affairs Plans. Maintain the site Quality Management System, and support external audits and conduct internal audits to ensure full compliance to required ISO13485 and FDA 21CFR820 requirements.
You should have proven ability in quality engineering/assurance environment, together with FDA and ISO 13485 quality assurance exposure. You should have through knowledge in the creation, deployment and support of Quality Systems, Processes and Tools. Have demonstrable ability to apply technical principles, practices and procedures across the whole organisation to ensure regulatory compliance required. This is a hands-on multi-task position and you must be able to provide clear and concise verbal and written communications across a wide range of audience, from senior management to engineers in R&D.
If you also have the following industry exposure that would be an added advantage:-
-Expertise in medical device new product introduction and design control, including software
-Design validation experience (hardware/software)
-Risk Management experience
-Internal Auditor experience
The minimum salary payable for this role is £46K. However, the client may pay up to £50K for a candidate who can meet all key requirements and abilities. Benefits include, private healthcare, pension.
For further information, please call Liz Collins or you can 'apply' by submitting your CV details for consideration. You will receive a call to discuss your technical strengths and career objectives.
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