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Job Location | Blackwood |
Education | Not Mentioned |
Salary | 35,000 - 38,000 per annum |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Permanent , full-time Work from home |
Reporting to the Head of QA you will be responsible for ensuring that regulatory and customer requirements are met, monitoring and identifying trends to provide early warning of potential quality issues.Client DetailsThe client are a medical device manufacturer based in Blackwood, South Wales. The company are part of a much larger group that have been established in the area for over 10 years.Description Perform internal audits to ISO 9001, 13485 and preferably ISO 14001 Assure ongoing compliance with quality and industry regulatory requirements Primary point of contact for shop floor associates relating to quality issue resolution Perform non-routine quality and product audits of the manufacturing area and product Quality monitoring and trending of production processes. Deliver insights and refereeing for the activities required to improve quality in the manufacturing processes Represent the Quality at production start-up meetings, delivering updates and briefings as required. Liaise with production to reduce scrap levels of production processes. Ensure that all work is performed to cGMP requirements and that the production area remains in a safe and tidy condition.Devise sampling procedures and directions for recording and reporting quality data Analyse data for trending to identify areas for improvement in the quality system Identify and provide quality training where necessary throughout the facility Investigate customer complaints and non-conformances Use problem solving tools, to achieve documented resolution of customer complaints, technical issues and non-conformances affecting the product or processes. Develop, recommend and monitor corrective and preventive actions Prepare reports to communicate outcomes of quality activities to senior management Support cross functional projects and continual improvementsProfileDegree qualified or with equivalent experience in an Engineering, Science or Technology discipline Preferably minimum of 3 years in a quality related field, beneficial if within a Medical Device design environment or equivalent regulatory controlled environment Full knowledge and understanding of the quality standards ISO 9001 and ISO 13485 Understanding of the environmental standard ISO 14001 beneficial. Full knowledge of quality and business management systems. Internal auditorQuality inspection experience Strong computer skills Experience using Quality tools such as root cause analysis and 8D Continuous improvement techniquesJob OfferSalary: £38,00024 days holidays, plus 8 bank holidayson-site parkingFlexible workingRemote working 1-2 days a week