Design Quality Engineer 6 Month Contract £33.15 p/h West Yorks

DESIGN QUALITY ENGINEER 6 MONTH CONTRACT £33.15 P/H WEST YORKS

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PROVEN KNOWLEDGE OF FDA AND MDD GMP REQUIREMENTS REGARDING MEDICAL DEVICES.
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FULL UNDERSTANDING AND EXPERIENCE OF INTERNAL AUDIT ADMINISTRATION, CAPA AND OPERATIONAL/EXECUTIVE MANAGEMENT REVIEW.
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HAVE A GOOD UNDERSTANDING OF GEOMETRIC DIMENSIONING AND TOLERANCING AND BE FULLY CONVERSANT WITH ENGINEERING DRAWINGS.
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A DEGREE LEVEL OR SIMILAR QUALIFICATION IN MECHANICAL OR INDUSTRIAL ENGINEERING.
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MINIMUM 2 YEARS' (5 YEARS FOR SENIOR) EXPERIENCE IN A QUALITY ROLE WITHIN A REGULATED INDUSTRY.
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PROVEN ABILITY TO SUCCESSFULLY MANAGE SIGNIFICANT CHANGE PROJECTS AND/OR INTRODUCE NEW PRODUCT DEVELOPMENT IN THE MEDICAL DEVICE (OR SIMILARLY REGULATED) INDUSTRY.
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PROVEN KNOWLEDGE AND ABILITY REGARDING PRODUCT VERIFICATION AND PROCESS VALIDATIONS.
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KNOWLEDGE AND UNDERSTANDING OF VALIDATION TECHNIQUES SUCH AS RISK ASSESSMENT, VALIDATION PLANNING, INSTALLATION QUALIFICATION (IQ), OPERATIONAL QUALIFICATION (OQ), PERFORMANCE QUALIFICATION (PQ), CHANGE CONTROL AND PROCESS VERIFICATION.
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HAVE THE PROVEN ABILITY TO INTERPRET AND CREATE ENGINEERING SPECIFICATIONS AND PROCEDURES.
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CREATION AND/OR MAINTENANCE ELEMENTS OF QUALITY SYSTEMS.
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STRONG INTERPERSONAL SKILLS.
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MUST BE PC LITERATE, AND FAMILIAR WITH MS OFFICE APPLICATIONS.