Senior Quality Engineer - Research and Development - Find My Rizq
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CooperVision

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, guaranteeing that medical 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 utility.Supports the upkeep and growth of further native and world high quality administration system parts.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 world 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 medical trial pattern manufacturing, new merchandise or course of growth, throughout all management phases, together with design evaluations, design, design change, design historical past recordsdata, and related danger administration actions.Develop and/or evaluation of medical trial pattern/product/course of growth documentation, take a look at 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 take care of Quality System Regulation necessities together with inside and exterior audits of Quality System.Support firm objectives and aims, insurance policies and procedures in compliance with high quality guide and high quality system processes similar to 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 throughout the facility.Works carefully with Regulatory Affairs, and Research and Development useful teams, to make sure compliance to relevant requirements (exterior and inside) similar to ISO, FDA-QSR and GMP.Participates, in Regulatory Agency Inspections of the amenities and ensures corrective actions are carried out as obligatory.Supports Manufacturing in Validation and Control Planning.KNOWLEDGE, SKILLS AND ABILITIES Technically sound in high quality methods and be abreast of developments within the Quality Assurance subject.Including sensible utility 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 best.Applied technical data of Qualitative and Quantitative knowledge evaluation, and statistical instruments.Six Sigma Green Belt certified or CQE best.Project Management certified best.Self-starter and in a position to work each independently and as a frontrunner of an built-in and interdisciplinary crew, finishing up assigned duties.Excellent interpersonal and written communication expertise to speak successfully in any respect ranges throughout the Quality Organisation, in addition to cross functionally with departments similar to R&D, Regulatory Affairs, Manufacturing, and Life Cycle Management.Effective teaching and mentoring expertise.Knowledge of MS-Office and, Agile.Minitab expertise best EXPERIENCE Desirable minimal 10 years associated expertise within the medical machine subject and/or coaching or equal mixture of schooling and expertise, together with expertise at administration stage.EDUCATION Bachelor in an engineering or science self-discipline at a minimal.Master’s diploma best.

Tagged as: care, education, engineer, intern, IT, ms office, research, science

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