Quality Engineer

Quality EngineerJob Description:The Quality Engineer will be a member of the Quality team and will support maintenance of the Quality System, ensuring compliance to Customers, Regulatory and Quality System Requirements.The activities will include, but are not limited to, maintaining quality system metrics, supporting validation activities, production activities, supporting change control activities and supporting risk management activities.The Quality Engineer will handle multiple projects and tasks, from product inception through to production, utilising a high level of written and oral communication skills.The Quality Engineer will be working as part of a team to maintain high quality and performance standards across multiple production lines, from receiving inspection to final release, including but not limited to validation, testing, and continuous monitoring of product/process performance.The Quality Engineer will play an active role in the processes to ensure products meet quality and compliance standards regulations while meeting all design controls, risk management, change control requirements and other applicable regulatory requirements.Roles & Responsibilities· Ability to manage and control multiple activities.Excellent attention to detail & organisation skills required.· Works closely with product development engineering and the client team to establish the product specifications and product specific requirements in relation to design input development.Participate in the generation of Design Input / Output documents.· Support the development / evolution of the Design Control, Risk Management and associated systems, to encompass new product development technologies.· Provide Design Assurance input to R&D project teams for designated projects, understanding the regulatory requirements for device development and providing input to projects to encompass these requirements.· Support risk management activities for designated projects and design changes.· Design, development and validation of test methods to support development programs.· Develop and maintain design verification and validation plans, protocols and reports.· Support R&D in the preparation and delivery of Design Reviews and associated checklists.· Establish and maintain the Design History File and associated documents.· Perform an active role in quality planning and new product introduction from a QA perspective.· Compile and report quality metrics.· Support regulatory, internal and customer audits.· Support equipment and process validation activities including generation / updates to MVP.· Manage quality engineering activities from receiving to final release, including but not limited to validation, testing, and continuous monitoring of product/process performance using applicable sampling and statistical techniques.· Support Quality culture within the organisation while providing training and guidance on applicable requirements / standards.· Provides manufacturing line support and provide Quality expertise in relation to Manufacturing issues and product disposition.· Have a good working knowledge of applicable medical device / testing standards.· Deals with suppliers and ensures their quality standards are in line with company standards.· Induction Training, GMP and GDP Training.· Perform other related duties as required.Requirements· Degree in Quality or Degree in Science / Engineering.· Experience within a similar role as quality engineer.· 4+yrs industry experience in a medical device design or manufacturing environment.· Working knowledge of FDA & ISO***** Quality systems for Medical device manufacturing.· New product introduction & manufacturing process transfer experience would be an advantage.· Quality experience in design assurance and device manufacturing desirable.· Proficient in MiniTab (or equivalent statistical software) and Microsoft Office applications e.g. Outlook, Word, Excel, Visio, PowerPoint, and Teams.· Strong interpersonal skills and the ability to communicate appropriately with different engineering teams, management, vendors and customers.Job Types: Full-time, PermanentBenefits:Bike to work schemeCompany pensionEmployee discountOn-site parkingPrivate medical insuranceSick payExperience:Medical Device or Manufacturing: 4 years (required)Quality assurance: 4 years (required)Work Location: In person