Quality Engineer

Thomas Professional ,
Chepstow, Gwent
More Details

Overview

Purpose of the Job Provide support for design/development and manufacture of medical devices including electrosurgical instruments. Specifically, for carrying out quality engineering processes and the generation and/or review and approval of associated records and ensuring compliance with the requirements of ISO 13485:2016 and US FDA quality system regulation. The role is essential to ensuring products are designed, developed and manufactured to a high quality and to supporting compliance to regulatory requirements. The role requires close and proactive working with design/development engineers and technicians, production, purchasing and materials control personnel and other Medical personnel as necessary. Key tasks for the position holder · Responsible for verifying that project teams are operating in compliance with Medical Standard Operating Procedures for new product development. · Offering pragmatic guidance on compliant routes to market that ensure robust documentary evidence and timely achievement of project goals. · Develop a professional working arrangement with the teams to promote quality values throughout. · Provide regulatory and quality education and training where appropriate. · Identifying and reporting deficiencies to the teams and management in accordance with the non-conformance process. · Be the risk management authority on the project team to ensure that there is a favourable risk/benefit ratio and suggest plans and strategies for reduction of risk. Review and approve the risk management output. · Review and approve all project related documentation that will be used to demonstrate compliance to regulatory requirements. · Develop the master validation plan for the introduction of manufacturing equipment and processes into production. Liaise with Manufacturing Engineers and operations to ensure that validation activities are planned, of sufficient depth and implemented effectively. · Review and approve validation protocols including IQ, OQ and PQ, providing support for any statistical techniques and analysis required. · Working closely with the design team, identify appropriate critical to quality features and generate first article inspection and goods receiving inspection plans, ensuring that appropriate measurement techniques are available. · Work with the Supplier Quality Engineer to ensure that the design supply base is sufficiently robust to ensure delivered product is compliant. · Review and approve verification and validation documentation to ensure that design outputs meet input requirements and that user needs are met. Ensure that verification test methods have been adequately validated before use. Support the team to identify suitable test methods and validation approaches Academic & professional qualifications required: Degree qualified in an engineering, medical or other relevant subject. · Must have previous experience in a Quality Engineering, Quality Assurance or Regulatory role in class II or class III medical devices environment. · There is an emphasis on candidates having experience of supporting new product development teams in a quality role i.e. supporting them through the regulatory pathway from the definition of a project to release to market primarily in the US or Europe. This will involve review and generation of technical file documentation and ensuring that teams are operating to the quality system and regulatory requirements. · Must have sufficient knowledge of the following regulations to act as the subject matter expert within the development team:- ISO 13485 and/or FDA 21 CFR part 820, BS EN 14971. · Working knowledge of ISO 10993, IEC 60601 ISO 11137 desirable. · An understanding of process validation, process control and statistics cleanroom manufacturer, electronics manufacturing techniques desirable. · Proactive · Able to work to deadlines · Attention to detail · Excellent people and communication skills · Sense of urgency - make things happen/get results · Reliable The THOMAS Recruitment Group are an Employment Business. We supply temporary, contract and permanent staff to various companies throughout the UK to various sectors. Located in South Wales, Midlands & the South West, we recruit for temporary and permanent job roles across the following core areas: INDUSTRIAL | DRIVING | FMCG | PROFESSIONAL | ONSITE If you are interested in this position, then please click ‘APPLY NOW’ below

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