JOB TITLE: Senior R&D Quality EngineerLOCATION: Pilot, Chandler’s Ford, HampshireSCOPE 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.Job SummaryResponsible for main QA Activities in Concept Research Control or Design Control actions, Risk Management within the R&D and Manufacturing, guaranteeing that scientific trial samples, new merchandise and new processes meet all necessities established by CooperVision procedures and acceptable regulatory necessities. Supports the upkeep and improvement of further native and international high quality administration system parts. Supports the worldwide high quality coverage and values of CooperVision.Essential Functions And AccountabilitiesMaintain 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 improvement, throughout all management phases, together with design opinions, design, design change, design historical past information, and related danger administration actions.Develop and/or evaluation of scientific trial pattern/product/course of improvement documentation, check methodology validation documentation, software program/laptop system validation documentation and course of validation documentation.Support R&D within the improvement of the inspection methodology and acceptance standards for sampling plans, together with the incoming, in-process, closing, and validation sampling plans as a part of the design improvement course of.Provide assist to take care of Quality System Regulation necessities together with inside and exterior audits of Quality System.Support firm objectives and goals, insurance policies and procedures in compliance with high quality guide and high quality system processes akin 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 inside the facility.Works carefully with Regulatory Affairs, and Research and Development practical teams, to make sure compliance to relevant requirements (exterior and inside) akin to ISO, FDA-QSR and GMP.Participates, in Regulatory Agency Inspections of the services and ensures corrective actions are carried out as essential.Supports Manufacturing in Validation and Control Planning.Knowledge, Skills And AbilitiesTechnically sound in high quality techniques and be abreast of developments within the Quality Assurance area. Including sensible utility of ISO 13485, ISO 14971 and FDA Quality System Regulation CFR 21 Part 820. MDSAP & MDD/ MDR is right.GMP expertise obligatory. GLP, or GCP, expertise splendid.Applied technical information of Qualitative and Quantitative information evaluation, and statistical instruments. Six Sigma Green Belt certified or CQE splendid.Project Management certified splendid.Self-starter and in a position to work each independently and as a pacesetter of an built-in and interdisciplinary group, finishing up assigned duties.Excellent interpersonal and written communication abilities to speak successfully in any respect ranges inside the Quality Organisation, in addition to cross functionally with departments akin to R&D, Regulatory Affairs, Manufacturing, and Life Cycle Management.Effective teaching and mentoring abilities.Knowledge of MS-Office and, Agile. Minitab expertise idealExperienceDesirable minimal 10 years associated expertise within the medical machine area and/or coaching or equal mixture of schooling and expertise, together with expertise at administration degree.EDUCATIONBachelor in an engineering or science self-discipline at a minimal. Master’s diploma splendid.