|Job Ref:||204646665||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Permanent||Country:||United Kingdom||County/State:||Glamorgan||City:||Cardiff||Address:||Post Code:||CF10||Salary:||£35000 - £40000/annum||Post Date:||09/10/2016 02:19|
Excellent Opportunity for a Senior Quality Engineer - to work with a well established Medical Devices Company - Competitive Salary and Benefits|
I am looking to recruit an experienced Quality Engineer with a background in a highly regulated environment. You will perform quality engineering activities to support safe, effective and compliant development and sustainment of the organisations medical device designs and manufacturing processes.
You will establish, implement and promote; quality planning, design control, process control, verification and validation activities to aid delivery of efficient designs and process providing safe, effective and compliant medical devices.
You will review and approve product and process documentation throughout the entire lifecycle to ensure compliant, effective and suitably robust design solutions are fully documented.
Ensure risk management process is effective and robust in identifying product and process risks and that risk migrations are implemented so as to ensure and compliant medical devices.
Support legal manufacturer's documentation requirements and technical enquiries to demonstrate company's state of the art regulatory solutions for applicable markets.
Apply and guide others in application of, industry standard statistical techniques to product and process including; measurement system analysis, capability assessment, statistical monitoring and control, hypothesis testing, sampling, sample size determination and screening, factorial and response surface modelling; Design of Experiments so as to provide objective, data based analysis and conclusions.
Provide and manage the application of problem solving tools, to achieve documented resolution of technical issues affecting the product or process.
Skills and Experience:
Degree qualified or with equivalent experience in Engineering, Science or Technology discipline
Preferably min of 3 years in a quality related field, beneficial if within a Medical Device design environment or equivalent regulatory controlled environment
Experience of quickly evolving environment with cross functional team working
Ability to interpret; technical standards, ethnical drawings and specifications with a good understanding of metrology and other measurement considerations
Strong understanding of range inferential statistical techniques, sampling techniques, MSA, DoE etc.
Sound understanding of risk management techniques including FMEA
Job Title: Senior Quality Engineer
Reference No: 228605
Job Type: Permanent
Salary: £35 - £40K
Please apply to Rachel Oliver, Senior Consultant, / (Apply online only)
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