Quality Engineer

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Quality Engineer / QA Engineer / Quality Validation Engineer / Validation Engineer Location: Glasgow, Central ScotlandSalary: DOEA Medical Device Manufacturer based in the central belt of Scotland area are seeking a Quality Engineer to join the team. This position will be validation focused so it is a key requirement that you hold a good understanding of validation activities. This Quality Engineer position is very much validation focused and my client are seeking someone has holds a good understanding of validation activities.Quality Engineer Role and Responsibilities:

'€¢IQOQPQ Protocols'€¢Provide Quality Engineering support as required to assist with protocol execution and/or oversight'€¢Provide Quality Engineering support and resource to assist with complaint and CAPA investigations and resolution'€¢Work collaboratively with other functional areas to effectively investigate and resolve product and process quality issues, deploying appropriate tools to assist root cause analysis and risk assessment'€¢Provide trending data and reports upon request to senior management, functional managers, regulatory authorities and customers'€¢In conjunction with the Risk Manager, provide QE input to improved dFMEAs and pFMEAs'€¢Champion the deployment and use of Master control as the electronic tool for the management of all test protocols and reports, validation data, engineering change orders and any records associated with design review or project meetings'€¢Develop training materials for design and manufacturing teams with respect to IQ/OQ/PQ validation requirements'€¢Assist with validation plans for new tools, machines and processes

Quality Engineer Candidate Requirements:

'€¢Knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CRF Part 820.  '€¢Experience of working in a medical device design environment with a strong quality focus.'€¢Strong leader, negotiator, influencer and communicator.'€¢Excellent organizational skills.'€¢Demonstration of good problem solving abilities.'€¢Influence internal project team and external parties to maximise success opportunities.'€¢Auditing against ISO13485. 

Apply by sending your updated CV through to [email protected] and call Laura on 0207 812 7700 to discuss your application in further detail. Interviews for this role are already being arranged.Medical / Medical Device / Validation / IQ/OQ/PQ / Quality / Auditing / Risk assessment / CAPA / Deviations / Protocols / Root cause analysis