Quality Assurance/ Quality Control Engineer

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Carrying out in coming goods inspections in line with quality control processes - generation, review and approval of records and ensuring compliance to the requirements of ISO 13485:2016 and MDD/MRD. If missing, QC processes shall be established.Perform final QC Inspection and Installation activities.Assist in the supplier management process, supplier selection, quality agreements, conduct supplier audits and measure supplier performance when required.Track and record equipment calibration status and ensure equipment is re-calibrated when required.Develop, generate, review and maintain documentation to support an effective and compliant Quality Management System, including: Quality Inspection Procedures and Control Plans; Material and Product Specifications; Process Flow Charts; Quality Systems and Process SOPs and Work Instructions; R&D Protocols & Reports; Product and Process FMEAs / Risk AssessmentsSupport company departments in maintaining the product technical files.Creating and maintaining the device history records (DHR1s)Rapid investigation of failure modes, establish root causes of product/process failures and establish resolution for non-conformities and customer feed-back & complaints.Assure Corrective and Preventive Action plans are developed and executed in compliance with the CAPA process.Assure engineering change principals are applied and change control process is followed in accordance with applied standards and regulations.Conduct, report and track internal quality audits.Develop and deliver Quality Systems training programs as required.Measure analyse and report performance data for company processes. Support line manager in creating Management Review Agenda.Support company departments with general quality and processes development and advice. Collaborate cross functionally to resolve Product Lifecycle Quality issues.Assist the design teams and manufacturing in identifying and resolving product/process problems (these include product release and production issues). They will ensure issues are fully closed out including full risk mitigation and compliance.Support the introduction of new products and processes into our contract manufacturer,Assist with verification & validation tests. To find out more about Huxley Engineering, please visit www.huxleyengineering.comHuxley Engineering, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales