Senior Quality Engineer - Research and Development - Find My Rizq
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JOB TITLE : Senior R&D Quality Engineer LOCATION : Pilot, Chandler’s Ford, Hampshire Responsible for main QA Activities in Concept Research Control or Design Control actions, Risk Management within the R&D and Manufacturing, making certain that scientific trial samples, new merchandise and new processes meet all necessities established by CooperVision procedures and acceptable regulatory necessities.Take the following step in your profession now – scroll right down to learn the complete position description and make your software.Supports the upkeep and growth of extra native and international high quality administration system components.Supports the worldwide high quality coverage and values of CooperVision.Work as a member of the CooperVision R&D QA division, liaising with all R&D departments throughout UK and US, in addition to Global manufacturing and distribution websites.ESSENTIAL FUNCTIONS AND ACCOUNTABILITIES Maintain and replace international procedures for Design Control and Risk Management that adheres to, ISO 13485, ISO 14971, MDSAP and MDD/ MDR.Lead and evaluation Concept Research Control or Design Control actions for scientific trial pattern manufacturing, new merchandise or course of growth, throughout all management phases, together with design critiques, design, design change, design historical past information, and related danger administration actions.Develop and/or evaluation of scientific trial pattern/product/course of growth documentation, check methodology validation documentation, software program/pc system validation documentation and course of validation documentation.Support R&D within the growth of the inspection methodology and acceptance standards for sampling plans, together with the incoming, in-process, ultimate, and validation sampling plans as a part of the design growth course of.Provide help to keep up Quality System Regulation necessities together with inner and exterior audits of Quality System.Support firm objectives and aims, insurance policies and procedures in compliance with high quality handbook and high quality system processes resembling CAPA system, Change Control, Management Review, Adverse Clinical Events or Customer Complaints, and Internal Audits.Creates a tradition of high quality consciousness, teamwork and cooperation with all teams inside the facility.Works carefully with Regulatory Affairs, and Research and Development purposeful teams, to make sure compliance to relevant requirements (exterior and inner) resembling ISO, FDA-QSR and GMP.Participates, in Regulatory Agency Inspections of the amenities and ensures corrective actions are carried out as needed.Supports Manufacturing in Validation and Control Planning.KNOWLEDGE, SKILLS AND ABILITIES Technically sound in high quality techniques and be abreast of developments within the Quality Assurance discipline.Including sensible software of ISO 13485, ISO 14971 and FDA Quality System Regulation CFR 21 Part 820.MDSAP & MDD/ MDR is right.GMP expertise necessary.GLP, or GCP, expertise ultimate.Applied technical information of Qualitative and Quantitative knowledge evaluation, and statistical instruments.Six Sigma Green Belt certified or CQE ultimate.Project Management certified ultimate.Self-starter and capable of work each independently and as a pacesetter of an built-in and interdisciplinary staff, finishing up assigned duties.Excellent interpersonal and written communication expertise to speak successfully in any respect ranges inside the Quality Organisation, in addition to cross functionally with departments resembling R&D, Regulatory Affairs, Manufacturing, and Life Cycle Management.Effective teaching and mentoring expertise.Knowledge of MS-Office and, Agile.Minitab expertise ultimate EXPERIENCE Desirable minimal 10 years associated expertise within the medical gadget discipline and/or coaching or equal mixture of training and expertise, together with expertise at administration degree.EDUCATION Bachelor in an engineering or science self-discipline at a minimal.Master’s diploma ultimate.

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